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)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
monoclonal antibody against protein CD20 primarily found on the surface of B-cells
Interferes with DNA replication
Rush University Medical Center
Chicago, Illinois, United States
Progression Free Survival
rate of progression in patients 2 years after diagnosis
Time frame: 2 year
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anthracycline antitumor antibiotic
Inhibits cell mitosis causing cell death.
a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases
stimulates the level of white blood cells (neutrophils).