Hodgkin DiseaseKLIONCT03942263
A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation
An observational study of Hodgkin Disease and Lymphoma, Large-cell, Anaplastic, run by Takeda at 50 sites in Russia.
Trial summary
The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Disease, Lymphoma, Large-cell, Anaplastic
- How many people
- 2,000 participants
- Where
- 50 sitesRussia
- Study dates
- 31 May 2019to 8 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with newly diagnosed cHL or sALCL, or with RR cHL or RR sALCL at the time of enrollment, or with RR cHL or RR sALCL within 3 years prior to inclusion in the study will be observed both retrospectively and prospectively.
Who may be able to join
- Male and female participants 18 years or older by the time of enrollment.
- Histologically confirmed diagnosis of cHL or sALCL.
- Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.
Who cannot join
- Unconfirmed diagnosis of cHL or sALCL.
- Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
- Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
- Participants for whom the minimum study dataset was not available from their hospital medical records.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Russia50 sites
State budgetary healthcare institution of the Astrakhan region Alexander-Mariinsky regional clinical hospital
Astrakhan, 414056
Autonomous Institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of Chuvashia
Cheboksary, 428020
State budgetary health care institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine"
Chelyabinsk, 454087
State Budget Public Health Institution "Regional Oncological Dispensary"
Irkutsk, 664035
Kaluga Regional Clinical Oncologic Dispensary
Kaluga, 248007
Tatarstan Regional Clinical Cancer Center
Kazan', 420029
State budgetary institution of health care of the Kemerovo region "Regional Clinical Oncology Center"
Kemerovo, 650036
Regional State Budgetary Institution of Health "Regional Clinical Hospital 1" named after Professor S.I. Sergeeva, Ministry of Health of the Khabarovsk Territory
Khabarovsk, 680009
Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency"
Kirov, 610027
Regional State Budgetary Institution of Health "Kostroma Oncological Dispensary"
Kostroma, 156005
Regional State Budgetary Institution of Health "Regional Clinical Hospital"
Krasnoyarsk, 660022
Regional State Budgetary Institution of Healthcare Krasnoyarsk Regional Clinical Oncologic Dispensary named after A.I. Kryzhanovsky"
Krasnoyarsk, 660133
Public health institution Lipetsk Regional Oncology Center
Lipetsk, 398005
State budgetary health care institution "Regional Oncology Center 2"
Magnitogorsk, 455001
Federal State Budgetary Institution "Main Military Clinical Hospital named after Academician N.N.Burdenko" of the Ministry of Defense of the Russian Federation
Moscow, 105094
Federal State Budgetary Institution "National Medical-Surgical Center named after N.I. Pirogov" Ministry of Health of the Russian Federation
Moscow, 105203
Federal State Budgetary Institution "National Medical Research Center of Oncology named after N.N. Blokhina "of the Ministry of Health of the Russian Federation
Moscow, 115478
The Moscow State Clinical Hospital No. 52 of the Moscow City Department of Healthcare, State Budgetary Institution of Health Care
Moscow, 123182
Federal State Institution National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation
Moscow, 125167
Moscow City Hematology Center on the basis of the State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital named after S.P. Botkin Moscow Department of Health
Moscow, 125284
State Budgetary Institution of Healthcare of the Moscow Region Moscow Regional Research Clinical Institute named after M.F. Vladimirskoye
Moscow, 129110
State Budgetary Healthcare Facility of Nizhny Novgorod Region "City Clinical Hospital 12"
Nizhny Novgorod, 603005
State budgetary institution of health care of the Nizhny Novgorod region "Regional Clinical Hospital named after NA Semashko"
Nizhny Novgorod, 603126
State Budgetary Institution of Healthcare of the Novosibirsk Region "City Clinical Hospital No. 2"
Novosibirsk, 630051
Federal State Budgetary Institution of Public Health of the Novosibirsk Region "Research Institute of Fundamental and Clinical Immunology"
Novosibirsk, 630075
State Budgetary Institution of Healthcare of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, 630087
Medical Radiological Research Center. A.F. Tsyba - a branch of the Federal State Budgetary Institution "Scientific Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation
Obninsk, 249031
Budget institution of healthcare of Omsk region "Clinical Oncologic dispensary"
Omsk, 644013
State budgetary institution of public health "Orenburg regional clinical hospital 1"
Orenburg, 460018
The State Budgetary Institution of Healthcare "Regional Oncologic Dispensary"
Penza, 440071
State Budgetary Institution of Healthcare of the Republic of Karelia Republican Hospital named after V. A. Baranova "
Petrozavodsk, 185019
State Budgetary Institution of Healthcare "Pskov Regional Clinical Oncologic Dispensary"
Pskov, 180004
Federal State Budgetary Educational Institution of Higher Education Rostov State Medical University of the Ministry of Health of the Russian Federation
Rostov-on-Don, 344022
Federal State Budgetary Educational Institution of Higher Education Ryazan State Medical University named after Academician I.P. Pavlova" of the Ministry of Health of the Russian Federation
Ryazan, 390026
Federal State Budgetary Educational Institution of Higher Education "North-Western State Medical University named after II Mechnikov" of the Ministry of Health of the Russian Federation
Saint Petersburg, 191015
Federal State Budgetary Institution "Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency"
Saint Petersburg, 191024
Federal State Budgetary Institution "N. N. Petrov National Medical Research Center of Oncology" of the Ministry of Health of Russia
Saint Petersburg, 191124
State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Saratov State Medical University named after V.I.Razumovsky of the Ministry of Health of Russia "Clinic of Physiopathology and Hematology named after Professor V.Ya. Shustov"
Saratov, 410028
Study State Budgetary Institution of Health "Oncology Dispensary No. 2" of the Ministry of Health of the Krasnodar Territory
Sochi, 354057
State Budgetary Institution of Healthcare of the Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
Stavropol, 355047
Budgetary institution of the Khanty-Mansiysk Autonomous Okrug Ugra
Surgut, 628408
State institution of the Komi Republic "Komi Republican Oncological Dispensary"
Syktyvkar, 167904
State Healthcare Institution of Tula Region "Tula Regional Clinical Hospital"
Tula, 300053
State autonomous health care institution of the Tyumen region "Multidisciplinary clinical medical center "Medical City"
Tyumen, 625041
Ministry of Health of the Republic of Bashkortostan State Autonomous Healthcare Institution Republican Clinical Oncologic Dispensary
Ufa, 450054
State Healthcare Institution "Regional Clinical Oncologic Dispensary"
Ulyanovsk, 432017
State budgetary health care institution "Volgograd Regional Clinical Oncology Center"
Volgograd, 400138
Budget institution of health care of the Vologda region "Vologda regional clinical hospital"
Vologda, 160002
State budgetary institution of health care of the Yaroslavl region "Regional Clinical Hospital"
Yaroslavl, 150062
About this study
Official title: KLIO - Non-interventional Multicenter Prospective and Retrospective Study to Describe Treatment Patterns and Disease Control in Patients With Classical Hodgkin's Lymphoma (cHL) and Systemic Anaplastic Large Cell Lymphoma (sALCL) in Routine Clinical Practice in the Russian Federation
The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.
Read the detailed description
This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice.
The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:
- Newly Diagnosed and RR cHL Participants
- Newly Diagnosed and RR sALCL Participants
This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.
- Conditions
- Hodgkin Disease, Lymphoma, Large-cell, Anaplastic
- Keywords
- Drug Therapy
- Medical subject headings
- Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed and RR cHL Participants | Participants diagnosed with RR cHL at the time of enrollment and RR cHL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed cHL, or RR cHL at the time of enrolment, or RR cHL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting. | |
| Newly Diagnosed and RR sALCL Participants | Participants diagnosed with RR sALCL at the time of enrollment and RR sALCL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed sALCL, or RR sALCL at the time of enrolment, or RR sALCL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of Treatment Patterns Used for cHL or sALCL
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants Receiving Various Chemotherapy Regimens
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT)
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons)
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT)
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Pre-SCT Therapy Regimens
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of First Line Treatment Patterns According to Prognostic Group
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Relapse/Refractory (RR) Treatment Patterns
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Secondary outcomes (42)
Overall Survival (OS)
OS is defined as the time passed from the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed.
Measured: From the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed (up to Month 24)
Disease Free Survival-1 (DSF1)
DFS1 is defined as the time from the date of complete remission after first line of therapy till relapse or till the latest date of participant observed.
Measured: From date of complete remission after first line of therapy up to relapse or till the latest date of participant observed (up to Month 24)
Freedom From Treatment Failure-1 (FFTF1)
FFTF1 is defined as the time passed from date of initiation first therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed.
Measured: From date of initiation first therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24)
Event Free Survival-1 (EFS1)
EFS-1 is defined as the time passed from date of initiation first line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed.
Measured: From date of initiation first therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen
CR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis less than (<) 10 millimeter (mm).
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Partial Remission (PR) Achieved by the end of Treatment Regimen
PR based on RECIST 1.1 is defined as greater than or equal to (>=) 30 percent (%) decrease in the sum of longest diameters (SLD) of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Overall Response Achieved by the end of Treatment Regimen
Overall response based on RECIST 1.1 is defined as the percentage of participants who have a PR or CR to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30% decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Stable Disease (SD) Achieved by the end of Treatment Regimen
SD based on RECIST 1.1 is defined as changes in the SLD of targeted lesions ranging between reduction of <10% to an increase by <20% without the appearance of a new lesion, and irrespective of positron emission tomography (PET) results.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Progression Disease (PD) While on the Treatment
PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Relapse (Both Early [<12 Months After the end of First Line Treatment] and Late Relapses)
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Primary Resistance
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Resistant Participants to the Second and Later Treatment Lines
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants in Whom Brentuximab Vedotin was Used
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Treatment Patterns Containing Brentuximab Vedotin in Clinical Practice
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Disease Free Survival (DFS) After the Treatment Line Including Brentuximab Vedotin Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line
DFS will be assessed after the treatment line including brentuximab vedotin based on the number of cycles of brentuximab vedotin performed within this Treatment Line. DFS is defined as the time from the date of complete remission till relapse or till the latest date of participant observed.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
FFTF Based on the Number of Cycles of Brentuximab Vedotin Performed Within the Treatment Line
FFTF will be assessed based on the number of cycles of brentuximab vedotin performed within this treatment line. FFTF is defined as the time passed from date of initiation therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed.
Measured: From initiation therapy date until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complication, death from any cause, or till observed (up to Month 24)
EFS Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line
EFS will be assessed based on the number cycles of brentuximab vedotin performed within this treatment line. EFS is defined as the time passed from date of initiation therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed.
Measured: From initiation therapy date until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
CR based on RECIST 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
Overall response is defined as the percentage of participants who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30 % decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Cycles of Brentuximab Vedotin Before and After Stem Cell Transplantation (SCT)
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis
Clinical variable will include stage, histological types, immunohistochemistry data (yes/no), ALK-status (negative/positive), prognostic groups, prognostic risk factors (International Prognostic Score (IPS), International Prognostic Index, Age-adjusted International Prognostic Index, International T-cell Lymphoma Project Score, Prognostic Index for peripheral T-cell lymphoma unspecified [PTCL-U] [PIT]), prognostic risk factors, and risk factors for relapse.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Clinical Variables for cHL and sALCL at the Time of Resistance/Relapses
Clinical variable will include stage, histological types, immunohistochemistry data (yes/no) and ALK-status (negative/positive).
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Primary Disease Diagnostic and Staging
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants for Whom PET and PET/CT Scan was Used for Interim Treatment Response Evaluation
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
OS Based on use of PET/CT Scan for Initial Disease Staging, Interim and Final Response Assessment During Frontline and Second Line Treatment
OS is defined as the time passed from the date of initiation of cHL or sALCL treatment until the date of death from any cause or till the latest date of participant observed. OS will be analyzed by Cox regression.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Timepoint of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)
Timepoints will include number of cycle after which the evaluation is performed and time from the start of last cycle of therapy.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants for Whom PET and PET/CT Scan Were Used to Evaluate Final Treatment Response
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Timepoint of Performing Final Response Evaluation With PET/CT scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)
Timepoints will include number of cycle after which the evaluation is performed and time from the start of last cycle of therapy.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Time of Performing PET and PET/CT Scan After SCT
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Imaging Patterns Used for Primary Disease Diagnostic and Staging in Different Regions of Russia
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Imaging Patterns Used for Treatment Response Evaluation
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Imaging Patterns Used for Disease Control of the Participants Being in Remission
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet
Healthcare resources will include hospitalizations and sick leave sheet.
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Hospitalizations
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Days Spent on Hospital Beds
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Sick Leaves
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Days Spent on Sick Leaves
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Disease Free Survival-2 (DSF2)
DFS2 is defined as the time from the date of complete remission after second line of therapy till relapse or till the latest date of participant observed.
Measured: From date of complete remission after second line of therapy up to relapse or till the latest date of participant observed (up to Month 24)
Freedom From Treatment Failure-2 (FFTF2)
FFTF2 is defined as the time passed from date of initiation second line therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed.
Measured: From date of initiation second therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24)
Event Free Survival-2 (EFS2)
EFS-2 is defined as the time passed from date of initiation second line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed.
Measured: From date of initiation second therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice
Measured: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start31 May 2019
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942263
- Sponsor's protocol ID
- CHL-5004
- Other IDs
- U1111-1229-0611
- Acronym
- KLIO
- Status last verified
- Jul 2024
- First submitted
- 7 May 2019
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KLIO - Non-interventional Multicenter Prospective and Retrospective Study to Describe Treatment Patterns and Disease Control in Patients With Classical Hodgkin's Lymphoma (cHL) and Systemic Anaplastic Large Cell Lymphoma (sALCL) in Routine Clinical Practice in the Russian Federation
- ClinicalTrials.gov ID
- NCT03942263
- Acronym / sponsor ID
- KLIO / CHL-5004
- Conditions
- Hodgkin Disease, Lymphoma, Large-cell, Anaplastic
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.
Detailed description
This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice.
The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:
- Newly Diagnosed and RR cHL Participants
- Newly Diagnosed and RR sALCL Participants
This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed and RR cHL Participants | – | –Participants diagnosed with RR cHL at the time of enrollment and RR cHL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed cHL, or RR cHL at the time of enrolment, or RR cHL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting. |
| Newly Diagnosed and RR sALCL Participants | – | –Participants diagnosed with RR sALCL at the time of enrollment and RR sALCL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed sALCL, or RR sALCL at the time of enrolment, or RR sALCL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with newly diagnosed cHL or sALCL, or with RR cHL or RR sALCL at the time of enrollment, or with RR cHL or RR sALCL within 3 years prior to inclusion in the study will be observed both retrospectively and prospectively.
Key inclusion criteria (3 listed)
- Male and female participants 18 years or older by the time of enrollment.
- Histologically confirmed diagnosis of cHL or sALCL.
- Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.
Key exclusion criteria (4 listed)
- Unconfirmed diagnosis of cHL or sALCL.
- Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
- Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
- Participants for whom the minimum study dataset was not available from their hospital medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of Treatment Patterns Used for cHL or sALCL
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants Receiving Various Chemotherapy Regimens
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Pre-SCT Therapy Regimens
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of First Line Treatment Patterns According to Prognostic Group
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Relapse/Refractory (RR) Treatment Patterns
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
42 secondary outcomes
Overall Survival (OS)
Time frame: From the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed (up to Month 24)
Disease Free Survival-1 (DSF1)
Time frame: From date of complete remission after first line of therapy up to relapse or till the latest date of participant observed (up to Month 24)
Freedom From Treatment Failure-1 (FFTF1)
Time frame: From date of initiation first therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24)
Event Free Survival-1 (EFS1)
Time frame: From date of initiation first therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Partial Remission (PR) Achieved by the end of Treatment Regimen
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Overall Response Achieved by the end of Treatment Regimen
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Stable Disease (SD) Achieved by the end of Treatment Regimen
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Progression Disease (PD) While on the Treatment
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Relapse (Both Early [<12 Months After the end of First Line Treatment] and Late Relapses)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Primary Resistance
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Resistant Participants to the Second and Later Treatment Lines
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants in Whom Brentuximab Vedotin was Used
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Treatment Patterns Containing Brentuximab Vedotin in Clinical Practice
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Disease Free Survival (DFS) After the Treatment Line Including Brentuximab Vedotin Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
FFTF Based on the Number of Cycles of Brentuximab Vedotin Performed Within the Treatment Line
Time frame: From initiation therapy date until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complication, death from any cause, or till observed (up to Month 24)
EFS Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line
Time frame: From initiation therapy date until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24)
Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Cycles of Brentuximab Vedotin Before and After Stem Cell Transplantation (SCT)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Clinical Variables for cHL and sALCL at the Time of Resistance/Relapses
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Primary Disease Diagnostic and Staging
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants for Whom PET and PET/CT Scan was Used for Interim Treatment Response Evaluation
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
OS Based on use of PET/CT Scan for Initial Disease Staging, Interim and Final Response Assessment During Frontline and Second Line Treatment
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Timepoint of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants for Whom PET and PET/CT Scan Were Used to Evaluate Final Treatment Response
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Timepoint of Performing Final Response Evaluation With PET/CT scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Time of Performing PET and PET/CT Scan After SCT
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Imaging Patterns Used for Primary Disease Diagnostic and Staging in Different Regions of Russia
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Imaging Patterns Used for Treatment Response Evaluation
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Imaging Patterns Used for Disease Control of the Participants Being in Remission
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Hospitalizations
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Days Spent on Hospital Beds
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Sick Leaves
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Number of Days Spent on Sick Leaves
Time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Disease Free Survival-2 (DSF2)
Time frame: From date of complete remission after second line of therapy up to relapse or till the latest date of participant observed (up to Month 24)
Freedom From Treatment Failure-2 (FFTF2)
Time frame: From date of initiation second therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- To obtain more information on the study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Disease and Lymphoma, Large-cell, Anaplastic, run by Takeda at 50 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of Treatment Patterns Used for cHL or sALCL (time frame: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.