drugset / Trial / NCT02815397
DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
Newly diagnosed histologically confirmed c-myc+ de novo DLBCL. Metformin 500 mg daily x 1 week, then 500 mg twice daily (BID) x 2 weeks, then 850 mg twice daily until 1 month after last cycle of chemo-immunotherapy. DA-EPOCH-R every 21 days x 4 cycles (CNS prophylaxis single or triple therapy given intrathecally each cycle to patients deemed appropriate by treating physician). Restage after 4 cycles with CT. Complete remission or partial remission: complete 2 more cycles or radiation therapy (XRT) consolidation per physician. Stable or progressive disease will go on to salvage therapy off study.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-07
- Completion
- 2016-07
Outcome
Outcome not reported
Stopped (Enrollment): “Poor accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 850 mg | — |