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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT02531308
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Jul 31, 2015
Status verified
Sep 2022
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-CHOP with Metformin
    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 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study. Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 2 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612-

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By research site
Rush University Medical Center· Chicago, IL

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