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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- STATUS
- Recruiting
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- End date
- Feb 21, 2023
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- participants needed
- 300
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- sponsor
- National Research Center for Hematology, Russia
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.
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).
Details
| Condition | Diffuse Large B-Cell Lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma |
|---|---|
| Treatment | R-DA-EPOCH-21, R-DA-EPOCH-21 + auto-SCT, R-mNHL-BFM-90, R-mNHL-BFM-90 + auto-SCT |
| Clinical Study Identifier | NCT02842931 |
| Sponsor | National Research Center for Hematology, Russia |
| Last Modified on | 21 January 2021 |
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