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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

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ClinicalTrials.gov Identifier: NCT02842931
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
National Research Center for Hematology
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia

Brief 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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: R-DA-EPOCH-21 Drug: R-DA-EPOCH-21 + auto-SCT Drug: R-mNHL-BFM-90 Drug: R-mNHL-BFM-90 + auto-SCT Phase 3

Detailed Description:

Patients initially are randomized into 4 arms:

  1. st arm R-DA-EPOCH-21
  2. nd arm R-mNHL-BFM-90
  3. rd arm R-DA-EPOCH-21 + auto-SCT
  4. 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Active Comparator: R-DA-EPOCH-21
Protocol involves 6 cycles.
Drug: R-DA-EPOCH-21
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
Drug: R-DA-EPOCH-21 + auto-SCT
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.

Drug: R-mNHL-BFM-90
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
Drug: R-mNHL-BFM-90 + auto-SCT
R-mNHL-BFM-90 with auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed DLBCL,
  2. No previous treatment with chemotherapy and/or radiation therapy of DLBCL
  3. Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
  4. Age 18-60 years.

Exclusion Criteria:

  1. Transformation of mature cell lymphomas in DLBCL.
  2. B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Hodgkin's lymphoma
  3. B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and Burkitt lymphoma
  4. DLBCL of central nervous system (CNS)
  5. testicular DLBCL
  6. Primary mediastinal large B-cell lymphoma
  7. Pretreated DLBCL.
  8. HIV-associated DLBCL
  9. Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction.
  10. 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).
  11. 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%.
  12. 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).
  13. 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.
  14. Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system.
  15. Decompensated diabetes.
  16. Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842931


Contacts
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Contact: Aminat Magomedova, MD, PhD 495-613-2446 ext 007 maminat@mail.ru
Contact: Sergay Kravchenko, MD PhD 495-613-2446 ext 007 krav-hsc-ramn@mail.ru

Locations
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Russian Federation
National Research Center for Hematology Recruiting
Moscow, Russian Federation, 125167
Contact: Aminat U Magomedova, MD, PhD    495-613-2446 ext 007    maminat@mail.ru   
Contact: Sergay K Kravchenko, MD, PhD    495-613-2446 ext 007    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         
Sponsors and Collaborators
National Research Center for Hematology, Russia
National Research Center for Hematology
Investigators
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Study Chair: Elena N Parovichnikova, MD PhD National Research Center for Hematology, Russia
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Responsible Party: Elena N.Parovichnikova, MD, PhD, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT02842931    
Other Study ID Numbers: DLBCL-2015
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Keywords provided by Elena N.Parovichnikova, National Research Center for Hematology, Russia:
DLBCL, R-DA-EPOCH-21, R-mNHL-BFM-90, auto-SCT
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Doxorubicin
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Anti-Inflammatory Agents