R-BL-M-04 Versus R-(DA)-EPOCH and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit (HGBL DH) and High-Grade B-cell Lymphoma Not Otherwise Specified (HGBL NOS)
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- STATUS
- Recruiting
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- End date
- Mar 15, 2024
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- participants needed
- 80
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- sponsor
- Elena N.Parovichnikova
Summary
Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-BL-04 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise Specified.
Description
Patients initially are randomized into 4 arms:
the first arm R-DA-EPOCH-21 the second arm R-BL-M-04 the third arm R-DA-EPOCH-21 + auto-SCT the fourth arm of R-BL-M-04 + auto-SCT Patients who achieved complete remission after 6 cycles of R-DA-EPOCH-21 or 4 cycles of R-BL-M-04 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 did not achieve complete remission with PET-CT data (4-5 Deauville points) are removed from the protocol and undergoing second-line therapy.
Details
| Condition | Lymphoma, High-Grade |
|---|---|
| Treatment | R-DA-EPOCH-21, R-DA-EPOCH-21 + auto-SCT, R-BL-M-04, R-BL-M-04 + auto-SCT |
| Clinical Study Identifier | NCT03479918 |
| Sponsor | Elena N.Parovichnikova |
| Last Modified on | 1 March 2022 |
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