Conditions: Diffuse Large B Cell Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP

Interventions: intervention 1: rituximab intervention 2: cyclophosphamide intervention 3: vincristine intervention 4: doxorubicin intervention 5: prednisone intervention 6: azacytidine
Intervention descriptions: intervention 1: 375 mg/m2 on Day 8 of each of 6 cycles intervention 2: 750 mg/m2 on Day 8 of each of 6 cycles intervention 3: 1.4 mg/m2 on Day 8 of each of 6 cycles intervention 4: 50 mg/m2 on Day 8 of each of 6 cycles intervention 5: 100 mg PO days 8-12 of each of 6 cycles intervention 6: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5

Protocol document: