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

Stopped early · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT02815397

Run by

Rush University Medical Center

People needed

2

Starts

2016-02-01

Expected to finish

2016-07-01

Last updated by the study team

2017-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 -

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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