drugset / Trial / NCT03837873
DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).
Timeline
- Start
- 2019-01-21
- Primary completion
- 2023-09-01
- Completion
- 2024-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 2 g | Intravenous |
| Subject | Dexamethasone | Small molecule | 30 mg | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Rituximab | Monoclonal antibody | 750 mg/m2 | Intravenous |
| Subject | Vincristine | Small molecule | 0.4 mg/m2 | Intravenous |