Hodgkin Lymphoma, AdultPhase 3HL-Russia-1NCT04638790
First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia (HL-Russia-1)
A Phase 3 study testing Doxorubicin, Bleomycin and Vinblastine in people with Hodgkin Lymphoma, Adult, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 2 sites in 2 countries.
Trial summary
The HL-Russia-1 is a non-randomized, open-label, multicenter, phase III, 3-arm study. The primary objective is to assess efficacy, safety and progression-free survival (PFS) of different approaches (earle favorable, early unfavorable and advanced stages) to first line chemotherapy for classical Hodgkin Lymphoma (HL). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hodgkin Lymphoma, Adult
- What is being tested?
- Doxorubicin, Bleomycin and Vinblastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2020to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Histologically confirmed classical HL
- Previously untreated disease
- Age 18-5 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
- Adequate organ and marrow function as defined below: absolute neutrophil count >1,0 x109/L, platelets >75 x109/L
- Total bilirubin <2 mg/dl without a pattern consistent with Gilbert's syndrome
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- Creatinine within normal institutional limits or creatinine clearance >50 mL/min/1.73 m2
- Females of childbearing must have a negative pregnancy test at medical supervision even if had been using effective contraception
- Life expectancy > 6 months
- Able to adhere to the study visit schedule and other protocol requirements
- Sign (or their legally acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Access to PET-CT (positron emission computed tomography) scans facilities
Who cannot join
- Nodular Lymphocyte Predominant HL
- Prior chemotherapy or radiation therapy
- Pregnant or lactating females
- Cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
- Abnormal QTc (corrected QT interval) interval prolonged (>450 msec in males; >470 msec in women)
- Uncontrolled infectious disease
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- Human immunodeficiency virus (HIV) positivity or active infectious A, B or C hepatitis. HBsAg-negative patients with anti-HBc (hepatitis B core antigen) antibody and can be enrolled provided that Hepatitis B Virus (HBV)-DNA are negative and that antiviral treatment with nucleos(t)ide analogs is provided
- Uncompensated diabetes
- Refusal of adequate contraception
- Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Opd-81 Main Building, Dr. E Borges Road, Parel 400012
Hasmukh Jain, Dr., 02224177018 ext. 7718982948, dr.hkjain@gmail.com
Lingaraj Nayak, Dr., 02224177018 ext. 7718982948
Russia1 site, 1 recruiting
- Recruiting
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation
Moscow, 105203
Vladislav Sarzhevskiy, MD, PhD, +74956037217, vladsar100@gmail.com
Nikita Mochkin, MD, PhD, +74956037217, nickmed@yandex.ru
About this study
Official title: First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia
The HL-Russia-1 is a non-randomized, open-label, multicenter, phase III, 3-arm study. The primary objective is to assess efficacy, safety and progression-free survival (PFS) of different approaches (earle favorable, early unfavorable and advanced stages) to first line chemotherapy for classical Hodgkin Lymphoma (HL).
Read the detailed description
The study is devoted to patients affected with Hodgkin Lymphoma in Russia.
The study aims to assess the efficacy and safety of three different approaches to first line chemotherapy for classical Hodgkin Lymphoma (HL):
- Early favourable (stages I-IIA without unfavorable risk factors). Patients will receive two courses of standard ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine). Those with a PET-2 (positron emission tomography) negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (20 Gy). Those with a PET-2 Deauville score 4 will proceed with additional 2 ABVD courses. After that, those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan after 4 ABVD cycles (Deauville score 4-5) patients will be planned to perform the biopsy and in case of positive results, proceed to high-dose chemotherapy with autologous stem cell transplantation (HDT with ASCT). In case of negative results of the biopsy, they will proceed with additional 2 ABVD courses and restage again. Those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT. Those with a PET-2 Deauville score 5 after 2 ABVD courses will be planned to perform the biopsy and in case of positive results, proceed to HDT with ASCT. In case of negative results of the biopsy they will proceed with additional 2 ABVD courses and restage again. Those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.
- Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, patients younger 50 years). Patients will receive two courses of EACODD-14 (etoposide 100 mg/m2 days 1-3, doxorubicin 50 mg/m2 day 1, cyclophosphamide 650 mg/m2 day 1, vincristine 1,4 mg/m2 day 8, dacarbazine 375 mg/m2 day 1, dexamethasone 20 mg days 1-3; cycle is repeated every 14 days). Those with a PET-2 negative scan (Deauville Score 1-3) will be deescalated to 2 courses of AVD (Adriamycin, vinblastine, and dacarbazine) and consolidative radiotherapy on initially involved site (30 Gy). Those with a PET-2-positive scan (Deauville score 4-5) will proceed with additional 2 EACODD-14 courses. After that, those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan after 4 EACODD-14 cycles (Deauville score 4-5) patients will proceed with additional 2 EACODD-14 courses. After that, those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.
- Advanced stages (younger 50 years). Patients will receive two courses of EACODD-14. Those with a PET-2 negative scan (Deauville Score 1-3) will proceed with 4 additional courses of EACODD-14. After that, patients with residual tumor ˂ 4 cm, will stop the therapy and start the follow-up phase. Patients with residual tumor ≥ 4 cm, will undergo consolidative radiotherapy on residual tumor (30 Gy). Those with a PET-2-positive scan (Deauville score 4-5) will proceed with additional 4 additional courses of EACODD-14. After that, those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on residual tumor ≥ 2,5 cm (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.
- Conditions
- Hodgkin Lymphoma, Adult
- Being tested
- Doxorubicin, Bleomycin, Vinblastine, Dacarbazine, Etoposide
- Keywords
- EACODD-14
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called ABVD
25 mg/m2 i.v. day 1,15 for ABVD/AVD
BleomycinDrug
Also called ABVD
10,000 units/m2 i.v. days 1,15 for ABVD
VinblastineDrug
Also called ABVD
6 mg/m2 i.v. days 1,15 for ABVD/AVD
DacarbazineDrug
Also called ABVD
375 mg/m2 i.v. days 1,15 for ABVD/AVD
EtoposideDrug
Also called EACODD-14
100 mg/m2 i.v. days 1-3
DoxorubicinDrug
Also called EACODD-14
50 mg/m2 i.v. day 1 for EACODD-14
CyclophosphamideDrug
Also called EACODD-14
650 mg/m2 i.v. day 1
VincristineDrug
Also called EACODD-14
1,4 mg/m2 i.v. day 8
DexamethasoneDrug
Also called EACODD-14
20 mg i.v. days 1-3
DacarbazineDrug
Also called EACODD-14
375 mg/m2 i.v. day 1 for EACODD-14
| Study group | Role | What they receive |
|---|---|---|
| Early favorable HL | Experimental | HL without adverse prognostic factors Receives: Drug: Doxorubicin; Drug: Bleomycin; Drug: Vinblastine; Drug: Dacarbazine |
| Early unfavorable HL | Experimental | Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, age less than 50 years) Receives: Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Dexamethasone |
| Advanced stages HL | Experimental | (age less than 50 years) Receives: Drug: Etoposide; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Dexamethasone; Drug: Dacarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate (CR)
CR rate is defined as the proportion of patients achieving a CR after 3 months of chemotherapy (interim) and at the end of treatment
Measured: up to 6 months
Acute Toxicity
The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)
Measured: 6 months
Late Toxicity
The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)
Measured: 5 years
Event-Free Survival (EFS)
EFS will be measured from the time from entry onto a study to any treatment failure including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of new treatment lacking documented progression, or death)
Measured: 5 years
Disease free survival (DFS)
DFS will be measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment
Measured: 5 years
Secondary outcomes (1)
Overall survival (OS)
OS is defined as the time from entry onto the clinical trial until death as a result of any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladislav Sarzhevskiy, PhD, Principal investigator, State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638790
- Sponsor's protocol ID
- HL-Russia-1
- Acronym
- HL-Russia-1
- Status last verified
- Sep 2024
- First submitted
- 16 Nov 2020
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Line Chemotherapy for Classical Hodgkin Lymphoma in Russia
- ClinicalTrials.gov ID
- NCT04638790
- Acronym / sponsor ID
- HL-Russia-1 / HL-Russia-1
- Conditions
- Hodgkin Lymphoma, Adult
- Keywords
- EACODD-14
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2020 (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 HL-Russia-1 is a non-randomized, open-label, multicenter, phase III, 3-arm study. The primary objective is to assess efficacy, safety and progression-free survival (PFS) of different approaches (earle favorable, early unfavorable and advanced stages) to first line chemotherapy for classical Hodgkin Lymphoma (HL).
Detailed description
The study is devoted to patients affected with Hodgkin Lymphoma in Russia.
The study aims to assess the efficacy and safety of three different approaches to first line chemotherapy for classical Hodgkin Lymphoma (HL):
- Early favourable (stages I-IIA without unfavorable risk factors). Patients will receive two courses of standard ABVD (Adriamycin, bleomycin, vinblastine, and dacarbazine). Those with a PET-2 (positron emission tomography) negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (20 Gy). Those with a PET-2 Deauville score 4 will proceed with additional 2 ABVD courses. After that, those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan after 4 ABVD cycles (Deauville score 4-5) patients will be planned to perform the biopsy and in case of positive results, proceed to high-dose chemotherapy with autologous stem cell transplantation (HDT with ASCT). In case of negative results of the biopsy, they will proceed with additional 2 ABVD courses and restage again. Those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT. Those with a PET-2 Deauville score 5 after 2 ABVD courses will be planned to perform the biopsy and in case of positive results, proceed to HDT with ASCT. In case of negative results of the biopsy they will proceed with additional 2 ABVD courses and restage again. Those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.
- Early unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, patients younger 50 years). Patients will receive two courses of EACODD-14 (etoposide 100 mg/m2 days 1-3, doxorubicin 50 mg/m2 day 1, cyclophosphamide 650 mg/m2 day 1, vincristine 1,4 mg/m2 day 8, dacarbazine 375 mg/m2 day 1, dexamethasone 20 mg days 1-3; cycle is repeated every 14 days). Those with a PET-2 negative scan (Deauville Score 1-3) will be deescalated to 2 courses of AVD (Adriamycin, vinblastine, and dacarbazine) and consolidative radiotherapy on initially involved site (30 Gy). Those with a PET-2-positive scan (Deauville score 4-5) will proceed with additional 2 EACODD-14 courses. After that, those with a PET-4 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-4 positive scan after 4 EACODD-14 cycles (Deauville score 4-5) patients will proceed with additional 2 EACODD-14 courses. After that, those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on initially involved site (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.
- Advanced stages (younger 50 years). Patients will receive two courses of EACODD-14. Those with a PET-2 negative scan (Deauville Score 1-3) will proceed with 4 additional courses of EACODD-14. After that, patients with residual tumor ˂ 4 cm, will stop the therapy and start the follow-up phase. Patients with residual tumor ≥ 4 cm, will undergo consolidative radiotherapy on residual tumor (30 Gy). Those with a PET-2-positive scan (Deauville score 4-5) will proceed with additional 4 additional courses of EACODD-14. After that, those with a PET-6 negative scan (Deauville Score 1-3) will proceed with radiotherapy on residual tumor ≥ 2,5 cm (30 Gy). In case of PET-6 positive scan (Deauville score 4-5) patients will be proceeded to HDT with ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early favorable HL | Experimental | Drug: Doxorubicin, Drug: Bleomycin, Drug: Vinblastine, Drug: DacarbazineHL without adverse prognostic factors |
| Early unfavorable HL | Experimental | Drug: Doxorubicin, Drug: Vinblastine, Drug: Dacarbazine, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Vincristine, Drug: DexamethasoneEarly unfavorable (stages IA-B, IIA bulky and/or extranodal lesions, age less than 50 years) |
| Advanced stages HL | Experimental | Drug: Etoposide, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Vincristine, Drug: Dexamethasone, Drug: Dacarbazine(age less than 50 years) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Histologically confirmed classical HL
- Previously untreated disease
- Age 18-5 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
- Adequate organ and marrow function as defined below: absolute neutrophil count >1,0 x109/L, platelets >75 x109/L
Key exclusion criteria (10 listed)
- Nodular Lymphocyte Predominant HL
- Prior chemotherapy or radiation therapy
- Pregnant or lactating females
- Cardiac arrhythmia, conduction abnormalities, ischemic cardiopathy, left ventricular hypertrophy or left ventricular ejection fraction (LVEF) ≤50% at echocardiography.
- Abnormal QTc (corrected QT interval) interval prolonged (>450 msec in males; >470 msec in women)
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 |
|---|---|---|
| DoxorubicinAlso: ABVD25 mg/m2 i.v. day 1,15 for ABVD/AVD | Drug | Early favorable HL, Early unfavorable HL |
| BleomycinAlso: ABVD10,000 units/m2 i.v. days 1,15 for ABVD | Drug | Early favorable HL |
| VinblastineAlso: ABVD6 mg/m2 i.v. days 1,15 for ABVD/AVD | Drug | Early favorable HL, Early unfavorable HL |
| DacarbazineAlso: ABVD375 mg/m2 i.v. days 1,15 for ABVD/AVD | Drug | Early favorable HL, Early unfavorable HL |
| EtoposideAlso: EACODD-14100 mg/m2 i.v. days 1-3 | Drug | Advanced stages HL, Early unfavorable HL |
| DoxorubicinAlso: EACODD-1450 mg/m2 i.v. day 1 for EACODD-14 | Drug | Advanced stages HL, Early unfavorable HL |
| CyclophosphamideAlso: EACODD-14650 mg/m2 i.v. day 1 | Drug | Advanced stages HL, Early unfavorable HL |
| VincristineAlso: EACODD-141,4 mg/m2 i.v. day 8 | Drug | Advanced stages HL, Early unfavorable HL |
| DexamethasoneAlso: EACODD-1420 mg i.v. days 1-3 | Drug | Advanced stages HL, Early unfavorable HL |
| DacarbazineAlso: EACODD-14375 mg/m2 i.v. day 1 for EACODD-14 | Drug | Advanced stages HL, Early unfavorable HL |
Primary outcome
Complete remission rate (CR)
Time frame: up to 6 months
CR rate is defined as the proportion of patients achieving a CR after 3 months of chemotherapy (interim) and at the end of treatment
Acute Toxicity
Time frame: 6 months
The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)
Late Toxicity
Time frame: 5 years
The severity of the toxicities will be classified according to definitions of Common Terminology Criteria for Adverse Event (CTCAE) version 4.3. It will be determined by the incidence of severe, life- threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (Infusion-related reactions)
Event-Free Survival (EFS)
Time frame: 5 years
EFS will be measured from the time from entry onto a study to any treatment failure including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of new treatment lacking documented progression, or death)
Disease free survival (DFS)
Time frame: 5 years
DFS will be measured from the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment
1 secondary outcome
Overall survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Vladislav Sarzhevskiy, PhD principal investigator
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxorubicin, Bleomycin and Vinblastine in people with Hodgkin Lymphoma, Adult, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 2 sites in 2 countries.
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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladislav Sarzhevskiy, PhD (+7-910-436-00-40, vladsar100@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (CR) (time frame: up to 6 months). The study lists 5 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 27 Sep 2024.