A Phase 2 interventional study of Metformin and Rituximab in Diffuse Large B-Cell Lymphoma, sponsored by Rush University Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) as documented by medical records and with histology based on criteria established by the World Health Organization
a. subtyping is required for DLBCL
Exclusion Criteria:
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
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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.
Drug: Metformin · Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone · Drug: pegfilgrastim
Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
Also known as: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet.
monoclonal antibody against protein CD20 primarily found on the surface of B-cells
Also known as: Rituxan, Zytux, Mab thera
Interferes with DNA replication
Also known as: Endoxan, Cytoxan, Neosar, Procytox, Revimmune, Cycloblastin
anthracycline antitumor antibiotic
Also known as: Adriamycin
Inhibits cell mitosis causing cell death.
Also known as: Oncovin
a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases
Also known as: Deltasone
stimulates the level of white blood cells (neutrophils).
Also known as: Neulasta
Progression Free Survival
rate of progression in patients 2 years after diagnosis
Time frame: 2 year
| Milestone | R-CHOP With Metformin |
|---|---|
| Started | 5 |
| Completed | 2 |
| Not completed | 3 |
rate of progression in patients 2 years after diagnosis
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| R-CHOP With Metformin | — | 1/5 (20%) | 5/5 (100%) |
| Event | R-CHOP With Metformin |
|---|---|
| Fever with urosepsisInfections and infestations | 1/5 |
| Pulmonary Embolism and DVTVascular disorders | 1/5 |
| Event | R-CHOP With Metformin |
|---|---|
| fatigueGeneral disorders | 5/5 |
| anemiaBlood and lymphatic system disorders | 4/5 |
| neutropeniaBlood and lymphatic system disorders | 3/5 |
| thrombocytopeniaBlood and lymphatic system disorders | 2/5 |
| cardiomyopathyCardiac disorders | 2/5 |
| hypoglycemiaEndocrine disorders | 1/5 |
| Age, Categorical(Participants) | R-CHOP With Metformin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | R-CHOP With Metformin |
|---|---|
| Female | 2 |
| Male | 3 |
Plan to share: Undecided
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