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R-DA-EPOCH-21 vs R-BL-M-04 +/- Auto-SCT in High-Grade B-cell Lymphoma
NCT03479918Phase 3
Key facts
- Status
- Unknown
- Start
- Mar 2018
- Primary completion
- Mar 2021
- Countries
- 1
- Modality
- Monoclonal Antibodies, DNA Intercalators/Alkylators, Stem Cell Therapies
- Conditions
- high grade B-cell lymphoma (HGBCL)
01
Overview
Phase 3, randomised, open-label trial of R-EPOCH, R-BL-M-04 and autologous hematopoietic stem cells in high grade B-cell lymphoma (HGBCL) (4 arms). Primary endpoints: Overall Survival at 2 years, Relapse-Free Survival at 2 years and 1 more. Status: unknown.
02
Design
4 arms- Study design
- RandomizedOpen-label
R-DA-EPOCH-21
R-DA-EPOCH-21 chemotherapy alone
R-BL-M-04
R-BL-M-04 chemotherapy alone
R-DA-EPOCH-21 + auto-SCT
R-DA-EPOCH-21 followed by Auto-SCT
R-BL-M-04 + auto-SCT
R-BL-M-04 followed by Auto-SCT
03
Who it enrols
Patients under 60 with newly diagnosed High-Grade B-cell Lymphoma (Double-hit or NOS), no prior treatment, and adequate organ function.
04
Endpoints
Primary
Overall Survival
Relapse-Free Survival
Progression
Secondary
Complete Remission
Partial Remission
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