Diffuse Large B-Cell LymphomaPhase 3NCT02842931
R-Dose-adjusted (DA) - EPOCH-21 Versus R-modified Non-Hodgkin Lymphoma (NHL)-Berlin-Frankfurt-Munster (BFM)-90 Program (mNHL-BFM-90) and Autologous Stem Cells Transplantation (Auto-SCT) in DLBCL With Poor Prognosis
A Phase 3 study testing R-DA-EPOCH-21, R-DA-EPOCH-21 + auto-SCT and R-mNHL-BFM-90 in people with Diffuse Large B-Cell Lymphoma, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with DLBCL with intermediate and high risk. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- R-DA-EPOCH-21, R-DA-EPOCH-21 + auto-SCT and R-mNHL-BFM-90
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2015to Feb 2023
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed DLBCL,
- No previous treatment with chemotherapy and/or radiation therapy of DLBCL
- Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
- Age 18-60 years.
Who cannot join
- Transformation of mature cell lymphomas in DLBCL.
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Hodgkin's lymphoma
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma
- DLBCL of central nervous system (CNS)
- testicular DLBCL
- Primary mediastinal large B-cell lymphoma
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- Pretreated DLBCL.
- HIV-associated DLBCL
- Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction.
- Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome).
- Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%.
- Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea > 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days).
- Life-threatening bleeding (gastrointestinal, intracranial), with exception of bleeding due to tumor infiltration of organs (stomach, intestines, uterus, etc.) and disseminated intravascular coagulation due to underlying disease complications after their successful conservative treatment.
- Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system.
- Decompensated diabetes.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
National Research Center for Hematology
Moscow, 125167
Aminat U Magomedova, MD, PhD, 495-613-2446 ext. 007, maminat@mail.ru
Sergay K Kravchenko, MD, PhD, 495-613-2446 ext. 007, krav-hsc-ramn@mail.ru
About this study
Official title: Multicenter, Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-mNHL-BFM-90 and (Auto-SCT)in Patients With DLBCL
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with DLBCL with intermediate and high risk.
Read the detailed description
Patients initially are randomized into 4 arms:
- st arm R-DA-EPOCH-21
- nd arm R-mNHL-BFM-90
- rd arm R-DA-EPOCH-21 + auto-SCT
- th arm of R-mNHL-BFM-90 + auto-SCT
Patients who achieved complete remission after 6 cycles of R-DA-EPOCH-21 or R-mNHL-BFM-90 immunochemotherapy continue to be under observation (1st and 2nd arms) or continue treatment with Rituximab + BCNU+Etoposid+Ara-C+Melphalan (R-BEAM) followed by auto-SCT (3rd and 4th arms). Patients who achieved partial remission after 6 cycles of R-DA-EPOCH-21 or R-mNHL-BFM-90 immunochemotherapy continue treatment with 2 cycles of Rituximab+Dexamethasone+Ara-C+Cisplatin (R-DHAP), continue to be under observation (1st and 2nd arms) or continue treatment with R-BEAM, followed by auto-SCT (3rd and 4th arms).
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- R-DA-EPOCH-21, R-DA-EPOCH-21 + auto-SCT, R-mNHL-BFM-90, R-mNHL-BFM-90 + auto-SCT
- Keywords
- DLBCL, R-DA-EPOCH-21, R-mNHL-BFM-90, auto-SCT
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-DA-EPOCH-21Drug
R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI
R-DA-EPOCH-21 + auto-SCTDrug
R-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI
R-mNHL-BFM-90Drug
R-mNHL-BFM-90 without auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI
R-mNHL-BFM-90 + auto-SCTDrug
R-mNHL-BFM-90 with auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI
| Study group | Role | What they receive |
|---|---|---|
| R-DA-EPOCH-21 | Active comparator | Protocol involves 6 cycles. Receives: Drug: R-DA-EPOCH-21 |
| R-DA-EPOCH-21 + auto-SCT | Active comparator | Protocol involves 6 cycles. Patients with complete remission undergo auto-SCT after 6 cycles and patients with partial remission after 6 cycles undergo auto-SCT after 2 cycles of R-DHAP Receives: Drug: R-DA-EPOCH-21 + auto-SCT |
| R-mNHL-BFM-90 | Active comparator | Course A:
Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Methotrexate 1000 mg/m2 12 h IV 1 day, Ifosfamide 800 mg/m2/day 1 h IV 1 - 5 days, Etoposide 100 mg/m2/day IV 4, 5 days, Doxorubicin 25 mg/m2/day IV 1, 2 days, Vincristine 2 mg IV 1 day, Cytarabine 100 mg/m2/day IV 1 h 4, 5 days.
Course B:
Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Cyclophosphamide 200 mg/m2/day IV 1 h 1 - 5 days, Methotrexate 1000 mg/m2 12 h IV 1 day, Doxorubicin 25 mg/m2/day IV 4, 5 days, Vincristine 2 mg IV 1 day. Protocol involves 6 cycles : A-B-A-B-A-B. One cycle continues 21 days. Receives: Drug: R-mNHL-BFM-90 |
| R-mNHL-BFM-90 + auto-SCT | Active comparator | Protocol involves 6 cycles R-mNHL-BFM-90: A-B-A-B-A-B. Patients with complete remission undergo auto-SCT after 6 cycles and patients with partial remission after 6 cycles undergo auto-SCT after 2 cycles of R-DHAP Receives: Drug: R-mNHL-BFM-90 + auto-SCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
(physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy).
Measured: 168 day
Secondary outcomes (3)
overall survival
Survival time and time to disease progression are calculated in months from day of enrollment in the study until death, relapse, progression, or last follow-up, as appropriate
Measured: Five-year survival
disease-free survival
Survival time and time to disease progression are calculated in months from day of enrollment in the study until death, relapse, progression, or last follow-up, as appropriate
Measured: Five-year survival
event-free survival
Survival time and time to disease progression are calculated in months from day of enrollment in the study until death, relapse, progression, or last follow-up, as appropriate
Measured: Five-year survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Collaborators
- National Research Center for Hematology
- Responsible party
- Principal investigator, Elena N.Parovichnikova, National Research Center for Hematology, Russia
- Investigators
- Elena N Parovichnikova, MD PhD, Study chair, National Research Center for Hematology, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842931
- Sponsor's protocol ID
- DLBCL-2015
- Status last verified
- Jul 2016
- First submitted
- 11 Mar 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH-21, R-mNHL-BFM-90 and (Auto-SCT)in Patients With DLBCL
- ClinicalTrials.gov ID
- NCT02842931
- Acronym / sponsor ID
- DLBCL-2015
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- DLBCL, R-DA-EPOCH-21, R-mNHL-BFM-90, auto-SCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Collaborators
- National Research Center for Hematology
- Study start
- Feb 2015
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 25 Jul 2016 (estimated)
- 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.
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-mNHL-BFM-90 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with DLBCL with intermediate and high risk.
Detailed description
Patients initially are randomized into 4 arms:
- st arm R-DA-EPOCH-21
- nd arm R-mNHL-BFM-90
- rd arm R-DA-EPOCH-21 + auto-SCT
- th arm of R-mNHL-BFM-90 + auto-SCT
Patients who achieved complete remission after 6 cycles of R-DA-EPOCH-21 or R-mNHL-BFM-90 immunochemotherapy continue to be under observation (1st and 2nd arms) or continue treatment with Rituximab + BCNU+Etoposid+Ara-C+Melphalan (R-BEAM) followed by auto-SCT (3rd and 4th arms). Patients who achieved partial remission after 6 cycles of R-DA-EPOCH-21 or R-mNHL-BFM-90 immunochemotherapy continue treatment with 2 cycles of Rituximab+Dexamethasone+Ara-C+Cisplatin (R-DHAP), continue to be under observation (1st and 2nd arms) or continue treatment with R-BEAM, followed by auto-SCT (3rd and 4th arms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| R-DA-EPOCH-21 | Active comparator | Drug: R-DA-EPOCH-21Protocol involves 6 cycles. |
| R-DA-EPOCH-21 + auto-SCT | Active comparator | Drug: R-DA-EPOCH-21 + auto-SCTProtocol involves 6 cycles. Patients with complete remission undergo auto-SCT after 6 cycles and patients with partial remission after 6 cycles undergo auto-SCT after 2 cycles of R-DHAP |
| R-mNHL-BFM-90 | Active comparator | Drug: R-mNHL-BFM-90Course A: Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Methotrexate 1000 mg/m2 12 h IV 1 day, Ifosfamide 800 mg/m2/day 1 h IV 1 - 5 days, Etoposide 100 mg/m2/day IV 4, 5 days, Doxorubicin 25 mg/m2/day IV 1, 2 days, Vincristine 2 mg IV 1 day, Cytarabine 100 mg/m2/day IV 1 h 4, 5 days. Course B: Rituximab 375 mg/m2 IV 0 day, Dexamethasone 10 mg/m2/day IV 1 - 5 days, Cyclophosphamide 200 mg/m2/day IV 1 h 1 - 5 days, Methotrexate 1000 mg/m2 12 h IV 1 day, Doxorubicin 25 mg/m2/day IV 4, 5 days, Vincristine 2 mg IV 1 day. Protocol involves 6 cycles : A-B-A-B-A-B. One cycle continues 21 days. |
| R-mNHL-BFM-90 + auto-SCT | Active comparator | Drug: R-mNHL-BFM-90 + auto-SCTProtocol involves 6 cycles R-mNHL-BFM-90: A-B-A-B-A-B. Patients with complete remission undergo auto-SCT after 6 cycles and patients with partial remission after 6 cycles undergo auto-SCT after 2 cycles of R-DHAP |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Newly diagnosed DLBCL,
- No previous treatment with chemotherapy and/or radiation therapy of DLBCL
- Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
- Age 18-60 years.
Key exclusion criteria (16 listed)
- Transformation of mature cell lymphomas in DLBCL.
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Hodgkin's lymphoma
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma
- DLBCL of central nervous system (CNS)
- testicular DLBCL
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 |
|---|---|---|
| R-DA-EPOCH-21R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI | Drug | R-DA-EPOCH-21 |
| R-DA-EPOCH-21 + auto-SCTR-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI | Drug | R-DA-EPOCH-21 + auto-SCT |
| R-mNHL-BFM-90R-mNHL-BFM-90 without auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI | Drug | R-mNHL-BFM-90 |
| R-mNHL-BFM-90 + auto-SCTR-mNHL-BFM-90 with auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI | Drug | R-mNHL-BFM-90 + auto-SCT |
Primary outcome
complete response
Time frame: 168 day
(physical examination, standard blood tests, including assessment of LDH level, thoracic and abdominal computerized tomography (together with any other anatomic site, as clinically indicated), bone marrow biopsy in case of bone marrow involvement and 18F-fludeoxyglucose positron emission tomography (18FDG-PET) (not mandatory) in case of residual measurable disease at the end of the chemoimmunotherapy).
3 secondary outcomes
overall survival
Time frame: Five-year survival
disease-free survival
Time frame: Five-year survival
event-free survival
Time frame: Five-year survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
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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.
Elena N Parovichnikova, MD PhD study chair
National Research Center for Hematology, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing R-DA-EPOCH-21, R-DA-EPOCH-21 + auto-SCT and R-mNHL-BFM-90 in people with Diffuse Large B-Cell Lymphoma, run by National Research Center for Hematology, Russia at 1 site 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aminat Magomedova, MD, PhD (495-613-2446 ext. 007, maminat@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response (time frame: 168 day). 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 25 Jul 2016; AzTrials last refreshed its copy on 1 Nov 2026.