drugset / Trial / NCT02815397

DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma

NCT02815397 ↗

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

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg —