NCT02531308

Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL)

A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)

Detailed description

Newly diagnosed histologically confirmed CD20 positive previously untreated diffuse large B-cell lymphoma to receive up to 4-6 cycles (21 day cycles) of: R-CHOP: Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 (cap @ 2mg) Prednisone 100mg PO daily Days 1-5 Pegfilgrastim 6 mg subcutaneously within 72 if start if cycle Metformin 500 mg PO daily Cycle 1 Days 1-7 Metformin 500 mg PO twice daily Cycle 1 Days 7-21 Metformin 850 mg PO twice daily starting on day 22 and and continuing throughout remainder of cycles plus 22 days post treatment. Restaging will be done after the 4th cycle is complete. Subjects will be monitored with labs and physical exams throughout the study.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Metformin	Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
DRUG	Rituximab	monoclonal antibody against protein CD20 primarily found on the surface of B-cells
DRUG	Cyclophosphamide	Interferes with DNA replication
DRUG	Doxorubicin	anthracycline antitumor antibiotic
DRUG	Vincristine	Inhibits cell mitosis causing cell death.
DRUG	Prednisone	a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases
DRUG	pegfilgrastim	stimulates the level of white blood cells (neutrophils).

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-08-24
• Last updated: 2022-09-28
• Results posted: 2017-01-27

Locations

1 site across 1 country: United States