- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842931
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
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Aminat Magomedova, MD, PhD
- Phone Number: 007 495-613-2446
- Email: maminat@mail.ru
Study Contact Backup
- Name: Sergay Kravchenko, MD PhD
- Phone Number: 007 495-613-2446
- Email: krav-hsc-ramn@mail.ru
Study Locations
-
-
-
Moscow, Russian Federation, 125167
- Recruiting
- National Research Center for Hematology
-
Contact:
- Aminat U Magomedova, MD, PhD
- Phone Number: 007 495-613-2446
- Email: maminat@mail.ru
-
Contact:
- Sergay K Kravchenko, MD, PhD
- Phone Number: 007 495-613-2446
- Email: krav-hsc-ramn@mail.ru
-
Principal Investigator:
- Aminat U Magomedova, MD, PhD
-
Sub-Investigator:
- Sergey K Kravchenko, MD, PhD
-
Sub-Investigator:
- Anna E Misurina, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: R-DA-EPOCH-21
Protocol involves 6 cycles.
|
R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI
|
Active Comparator: R-DA-EPOCH-21 + auto-SCT
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
|
R-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI
|
Active Comparator: R-mNHL-BFM-90
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. |
R-mNHL-BFM-90 without auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI
|
Active Comparator: R-mNHL-BFM-90 + auto-SCT
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
|
R-mNHL-BFM-90 with auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
168 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: Five-year 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
|
Five-year survival
|
disease-free survival
Time Frame: Five-year 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
|
Five-year survival
|
event-free survival
Time Frame: Five-year 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
|
Five-year survival
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Elena N Parovichnikova, MD PhD, National Research Center for Hematology, Russia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Etoposide
- Prednisone
- Doxorubicin
- Vincristine
Other Study ID Numbers
- DLBCL-2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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