drugset / Trial / NCT01004991
Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
Phase 1/2
Completed
14 enrolled
Weill Medical College of Cornell University
Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.
Timeline
- Start
- 2010-01
- Primary completion
- 2013-09
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 25 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 50 mg/m2 | — |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | — |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | — |