drugset / Trial / NCT02343536
A Phase 1, Open-label Trial of Oral Azacitidine (CC-486) Plus RCHOP in Subjects With Large B-Cell Lymphoma or Follicular Lymphoma or Transformed Lymphoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of the study is to identify a dose and schedule of CC-486 that can be safely administered with R-CHOP. To evaluate the safety and maximum tolerated dose (MTD) or the maximal administered dose (MAD) of CC-486 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with high risk (IPI 2 or more) previously untreated DLBCL or Grade 3B FL. Also, to determine pharmacokinetics (PK) of CC-486 when administered alone and in combination with R-CHOP and to explore preliminary efficacy of CC-486 plus R-CHOP by 2007 International Working Group (IWG) criteria.
Timeline
- Start
- 2015-04-29
- Primary completion
- 2020-01-29
- Completion
- 2020-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 100 mg | Oral |
| Subject | Azacitidine | Other / unclassified | 150 mg | Oral |
| Subject | Azacitidine | Other / unclassified | 200 mg | Oral |
| Subject | Azacitidine | Other / unclassified | 300 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |
| Background | Vincristine | Small molecule | — | — |