Hodgkin LymphomaNCT06104878
A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone
An observational study of Hodgkin Lymphoma, run by Takeda at 6 sites in Brazil.
Trial summary
The main aim of this study conducted in Brazil is to understand if there is a difference in the length of time that Classical Hodgkin's Lymphoma (cHL) does not grow or spread further (also called progression free survival or PFS), and in the length of time that participants live with cHL if they are treated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 0 participants
- Where
- 6 sitesBrazil
- Study dates
- 31 Dec 2023to 31 Oct 2024
- 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 diagnosed of advanced cHL treated with A+AVD or ABVD as first-line systemic therapy in Brazil.
Who may be able to join
- Histologically confirmed diagnosis of advanced cHL (International Classification of Diseases and Related Health Problems 10th Revision [ICD-10] code C81.X). The diagnosis of cHL will be confirmed according to World Health Organization (WHO) classification. Advanced disease is defined as having the diagnosis at stage IIB, III or IV, based on Ann Arbor classification.
- Who received at least one full cycle of A+AVD or ABVD regimen as first-line treatment (first systemic therapy for cHL management; systemic therapy naïve participants) from July, 1st 2017 to December, 31st 2020; and who completed the 6-cycle treatment until the end of December 2020.
- At least 2 years of retrospective information from the index date (treatment window) and at least 2 years of follow-up (after the end of treatment).
Who cannot join
- With previous or concurrent malignancies, except participants with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin.
- Who are simultaneously participating in another study.
- Who participated in the ECHELON-1 Clinical Study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Instituto D'Or de Pesquisa e Ensino
Brasília, Federal District, 70390-140
Oncoclinicas Rio de Janeiro S.A
Rio de Janeiro, 22250-905
Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia, 41253-190
Beneficência Portuguesa de São Paulo - Real Benemerita Associação Portuguesa de Beneficência
São Paulo, 01321-001
Hospital Alemão Oswaldo Cruz - HAOC
São Paulo, 01327-001
AC Camargo Cancer Center / Fundação Antonio Prudente Liberdade
São Paulo, 09015-010
About this study
Official title: Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
The main aim of this study conducted in Brazil is to understand if there is a difference in the length of time that Classical Hodgkin's Lymphoma (cHL) does not grow or spread further (also called progression free survival or PFS), and in the length of time that participants live with cHL if they are treated with Brentuximab Vedotin in combination with chemotherapy (A+AVD) or chemotherapy alone (ABVD).
A+AVD includes Brentuximab Vedotin + Doxorubicin + Vinblastine + Dacarbazine; ABVD includes Doxorubicin + Bleomycin + Vinblastine + Dacarbazine.
The study will be conducted by reviewing and collecting already existing medical records.
Read the detailed description
This is an observational, multicenter and retrospective study to evaluate the effectiveness of A+AVD regimen compared to ABVD regimen as first-line therapy for the treatment of Brazilian participants with advanced cHL diagnosis.
The study will enroll approximately 200 participants who were treated with A+AVD or ABVD as first line therapy for at least one full cycle of 28 days, from July 1st, 2017, to December 31st, 2020. Participants will be identified from medical charts and will be assigned into following treatment groups:
- ABVD: Doxorubicin 25 milligrams per square meter (mg/m^2) + Bleomycin 15 milligram (mg) + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2
- A+AVD: Brentuximab Vedotin 1.2 milligrams per kilogram (mg/kg) + Doxorubicin 25 mg/m^2 + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2
This multi-center trial will be conducted in Brazil. The duration of the study will be 12 months. Participants will be followed up for at least 2 years after the last therapy cycle (treatment window considered for the study from July 1st, 2017, to December 31st, 2020).
- Conditions
- Hodgkin Lymphoma
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| ABVD: Doxorubicin 25 mg/m^2 + Bleomycin 15 mg + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2 | Participants treated with doxorubicin 25 mg/m^2, bleomycin 15 mg, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 as first line therapy in each 28-day cycle for up to 6 cycles from July 1st, 2017, to December 31st, 2020, will be observed retrospectively. Receives: Other: No Intervention | |
| A+AVD: Brentuximab Vedotin 1.2mg/kg+Doxorubicin 25mg/m^2 +Vinblastine 6mg/m^2 +Dacarbazine 375mg/m^2 | Participants treated with brentuximab vedotin 1.2 mg/kg, doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 as first line therapy in each 28-day cycle for up to 6 cycles from July 1st, 2017, to December 31st, 2020, will be observed retrospectively. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The PFS will be calculated as the time (months) from the index date to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
Measured: From the index date (treatment start date) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first (up to 5.5 years)
Secondary outcomes (13)
Overall Survival (OS)
The OS is defined as time from index date (treatment start date) to death by any cause during the study follow-up period.
Measured: From index date (treatment start date) to death by any cause during the study follow-up period (up to 5.5 years)
Number of Participants Stratified by Vital Status on Last Follow up Visit
Latest information about participants vital status (alive, death, lost of follow-up) will be reported.
Measured: Up to approximately 5 years (Follow-up Period)
Number of Deaths and Cause of Deaths
Number of deaths and different cause of deaths will be reported.
Measured: Up to approximately 5.5 years
Time to Next Treatment (TTNT)
The TTNT is defined as interval from the date of initiation of a treatment to the date of commencement of the next line of therapy.
Measured: From the date of initiation of a treatment to the date of commencement of the next line of therapy (up to 5.5 years)
Treatment-Free-Interval (TFI)
The TFI is defined as interval between the end of one regimen and the start of the next regimen (death or the end of follow-up are censoring events).
Measured: Up to approximately 5.5 years
Number of Participants With Serious Adverse Events (SAEs) During Follow-up Period
A SAE is defined as signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.
Measured: Up to approximately 5 years (Follow-up Period)
Number of Participants With Adverse Events (AEs) During follow-up Period
An adverse event (AE) is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product (including peripheral neuropathy and neutropenia).
Measured: Up to approximately 5 years (Follow-up Period)
Number of Participants With AEs Leading to Drug Discontinuation or Dose Reduction During Follow-up Period
An AE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Measured: Up to approximately 5 years (Follow-up Period)
Number of Participants With Most Common SAEs and Total AEs During Follow-up Period
A SAE is defined as signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. Most common SAEs are defined as most frequent SAEs occurred during the study. An AE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Measured: Up to approximately 5 years (Follow-up Period)
Number of Treatment Cycles Participants Received
Number of treatment cycles received by participants will be reported. The length of each treatment cycle will be 28 days.
Measured: Up to approximately 6 months
Percentage of Participants With Completed Treatment Cycles
Participant who completed 6 cycles of treatment during the treatment window (July 1, 2017, to December 31, 2020) will be considered completed. The length of each treatment cycle will be 28 days.
Measured: Up to approximately 6 months
Number of Participants With Treatment Interruption and Main Reasons
Number of participant's that interrupted their treatment and the main reason will be reported. Reasons includes economical (example, healthcare insurance issues, cost-related, access barriers, etc.), participant's decision, adverse event (including toxicity), diseases progression, medical decision, death, other.
Measured: Up to approximately 6 months
Number of Participants With Comorbidities and Comorbidities per Type
Comorbidities may include diabetes, obesity, autoimmune disease (example, arthritis, lupus and others), infectious disease (example, human immunodeficiency virus, Epstein Barr virus), cardiovascular disease (example, congestive heart failure, rhythm abnormalities, hypertension), dyslipidemia, cerebrovascular disease, gastrointestinal disease (example, gastritis, ulcer), pulmonary disease (example, chronic pulmonary disease, chronic obstructive disease), liver disease, renal disease, thyroid disease, depression, neurologic (example neuropathies), other cancers, and others.
Measured: Up to approximately 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start31 Dec 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: Company decision after projects re-evaluation, taken before the study initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104878
- Sponsor's protocol ID
- Brentuximab-5021
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
- ClinicalTrials.gov ID
- NCT06104878
- Acronym / sponsor ID
- Brentuximab-5021
- Conditions
- Hodgkin Lymphoma
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company decision after projects re-evaluation, taken before the study initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 27 Oct 2023 (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 main aim of this study conducted in Brazil is to understand if there is a difference in the length of time that Classical Hodgkin's Lymphoma (cHL) does not grow or spread further (also called progression free survival or PFS), and in the length of time that participants live with cHL if they are treated with Brentuximab Vedotin in combination with chemotherapy (A+AVD) or chemotherapy alone (ABVD).
A+AVD includes Brentuximab Vedotin + Doxorubicin + Vinblastine + Dacarbazine; ABVD includes Doxorubicin + Bleomycin + Vinblastine + Dacarbazine.
The study will be conducted by reviewing and collecting already existing medical records.
Detailed description
This is an observational, multicenter and retrospective study to evaluate the effectiveness of A+AVD regimen compared to ABVD regimen as first-line therapy for the treatment of Brazilian participants with advanced cHL diagnosis.
The study will enroll approximately 200 participants who were treated with A+AVD or ABVD as first line therapy for at least one full cycle of 28 days, from July 1st, 2017, to December 31st, 2020. Participants will be identified from medical charts and will be assigned into following treatment groups:
- ABVD: Doxorubicin 25 milligrams per square meter (mg/m^2) + Bleomycin 15 milligram (mg) + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2
- A+AVD: Brentuximab Vedotin 1.2 milligrams per kilogram (mg/kg) + Doxorubicin 25 mg/m^2 + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2
This multi-center trial will be conducted in Brazil. The duration of the study will be 12 months. Participants will be followed up for at least 2 years after the last therapy cycle (treatment window considered for the study from July 1st, 2017, to December 31st, 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABVD: Doxorubicin 25 mg/m^2 + Bleomycin 15 mg + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2 | – | Other: No InterventionParticipants treated with doxorubicin 25 mg/m^2, bleomycin 15 mg, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 as first line therapy in each 28-day cycle for up to 6 cycles from July 1st, 2017, to December 31st, 2020, will be observed retrospectively. |
| A+AVD: Brentuximab Vedotin 1.2mg/kg+Doxorubicin 25mg/m^2 +Vinblastine 6mg/m^2 +Dacarbazine 375mg/m^2 | – | Other: No InterventionParticipants treated with brentuximab vedotin 1.2 mg/kg, doxorubicin 25 mg/m^2, vinblastine 6 mg/m^2, and dacarbazine 375 mg/m^2 as first line therapy in each 28-day cycle for up to 6 cycles from July 1st, 2017, to December 31st, 2020, will be observed retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed of advanced cHL treated with A+AVD or ABVD as first-line systemic therapy in Brazil.
Key inclusion criteria (3 listed)
- Histologically confirmed diagnosis of advanced cHL (International Classification of Diseases and Related Health Problems 10th Revision [ICD-10] code C81.X). The diagnosis of cHL will be confirmed according to World Health Organization (WHO) classification. Advanced disease is defined as having the diagnosis at stage IIB, III or IV, based on Ann Arbor classification.
- Who received at least one full cycle of A+AVD or ABVD regimen as first-line treatment (first systemic therapy for cHL management; systemic therapy naïve participants) from July, 1st 2017 to December, 31st 2020; and who completed the 6-cycle treatment until the end of December 2020.
- At least 2 years of retrospective information from the index date (treatment window) and at least 2 years of follow-up (after the end of treatment).
Key exclusion criteria (3 listed)
- With previous or concurrent malignancies, except participants with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin.
- Who are simultaneously participating in another study.
- Who participated in the ECHELON-1 Clinical Study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention will be administered in this study. | Other | A+AVD: Brentuximab Vedotin 1.2mg/kg+Doxorubicin 25mg/m^2 +Vinblastine 6mg/m^2 +Dacarbazine 375mg/m^2, ABVD: Doxorubicin 25 mg/m^2 + Bleomycin 15 mg + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2 |
Primary outcome
Progression Free Survival (PFS)
Time frame: From the index date (treatment start date) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first (up to 5.5 years)
The PFS will be calculated as the time (months) from the index date to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
13 secondary outcomes
Overall Survival (OS)
Time frame: From index date (treatment start date) to death by any cause during the study follow-up period (up to 5.5 years)
Number of Participants Stratified by Vital Status on Last Follow up Visit
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Deaths and Cause of Deaths
Time frame: Up to approximately 5.5 years
Time to Next Treatment (TTNT)
Time frame: From the date of initiation of a treatment to the date of commencement of the next line of therapy (up to 5.5 years)
Treatment-Free-Interval (TFI)
Time frame: Up to approximately 5.5 years
Number of Participants With Serious Adverse Events (SAEs) During Follow-up Period
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Participants With Adverse Events (AEs) During follow-up Period
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Participants With AEs Leading to Drug Discontinuation or Dose Reduction During Follow-up Period
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Participants With Most Common SAEs and Total AEs During Follow-up Period
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Treatment Cycles Participants Received
Time frame: Up to approximately 6 months
Percentage of Participants With Completed Treatment Cycles
Time frame: Up to approximately 6 months
Number of Participants With Treatment Interruption and Main Reasons
Time frame: Up to approximately 6 months
Number of Participants With Comorbidities and Comorbidities per Type
Time frame: Up to approximately 5.5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Study Director study director
Takeda
6 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 Lymphoma, run by Takeda at 6 sites in Brazil.
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 3 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: withdrawn, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. 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 was withdrawn before enrolling participants, so there are no results.
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?
Progression Free Survival (PFS) (time frame: From the index date (treatment start date) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first (up to 5.5 years)). 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 6 Mar 2024.