Clinical trial · Interventional
DA-EPOCH-Rituximab/Metformin (RM) for Double Hit Lymphoma
DA-EPOCH-RM: A Phase II Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (DA-EPOCH-R) for Previously Untreated C-myc+ Diffuse Large B-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm, open label
- description
- Metformin added to standard of care treatment for all patients
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Evaluation of Impact of Metformin on 18 Month Progression-free Survival
- timeFrame
- 18 month
- description
- Progression-free survival determined by CT scans at 18 months
Secondary outcomes (3)
- measure
- Effect of Metformin Overall Response Rate
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥ 18 years of age * Diagnosis of DLBCL as documented by medical records and with histology based on criteria established by the World Health Organization * subtyping is required for DLBCL * c-myc+ defined as presence of c-myc breaks by karyotype/FISH and/or IHC ≥ 40%; this includes double hits (with bcl-2 breaks found using cytogenetics/FISH) and/or double expressors (with bcl-2 protein expression ≥ 70% by IHC); increased copy number in itself is not considered positivity for c-myc * No prior therapy for diagnosis of DLBCL with exception of steroids * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2 (Appendix B) * Life expectancy of at least 6 months * No history of medication dependent diabetes mellitus * No evidence of acute or chronic metabolic acidosis (baseline venous lactate ≤ 4) Exclusion Criteria * Patient already on any class of anti-diabetic medication including metformin, insulin analogues, sulfonylureas, thiazolidinediones (TZDs) and the incretin-based therapies or clear need for therapeutic intervention based on fasting blood glucose * Known histological transformation from indolent non-Hodgkin Lymphoma (iNHL) or chronic lymphocytic leukemia (CLL) to an aggressive form of non-Hodgkin's lymphoma (NHL) (ie, Richter transformation) * Burkitt and/or precursor lymphoblastic leukemia/lymphoma. * Presence of known intermediate- or high-grade myelodysplastic syndrome * History of an active of treated non-lymphoid malignancy within the last 3 years excluding basal cell and squamous cell skin cancers * Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug. * Subjects who have currently active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per investigator assessment) * Renal insufficiency with creatinine \> 1.5 x upper limit of normal (ULN) OR creatinine clearance of \< 45 ml/min as calculated by the Cockcroft-Gault method * CNS or leptomeningeal involvement of lymphoma * HIV positive * Ongoing inflammatory bowel disease * Ongoing alcohol or drug addiction * Pregnancy or breastfeeding * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation -
References
Publications (0)
Data not yet available