Clinical trial · Interventional
Rituximab, Cyclophosphamide, Vincristine and Prednisone (R-CHOP) Plus Metformin in Diffuse Large-B-cell Lymphoma
Effect of Metformin in Combination With R-CHOP for the First Line Treatment of Patients With Diffuse Large B-cell Lymphoma
NCT03200015CI-TRIAL-00062002completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy for patients with newly diagnosed diffuse large-B cell lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin arm
- description
- Metformin 850 mg tablets. Initial dose 425 mg twice a day for 1 week, followed by 850 mg twice a day for 1 week, titrated to a maximum dose 850 mg every 8 hours until disease response evaluation study date (Computed tomography or positron emission tomography)
- interventionNames
- Drug: Metformin
Primary outcomes (2)
- measure
- Incidence of treatment-emergent adverse events
- timeFrame
- 6 months
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- measure
- Response rates
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed nodal diffuse large-B cell non Hodgkin lymphoma according to the 2008 World Health Organization classification for lymphoid malignancies * No previous treatment other than prednisone or equivalent glucocorticoid up to 60 mg/m2 for 14 days * Good performance status (Eastern Cooperative Oncology Group scale 0-2) * Life expectancy \>6 months * Independently of the diagnosis of diabetes mellitus (any type) Exclusion Criteria: * History of intolerance or hypersensitivity reactions to metformin * Primary central nervous system lymphoma * History of other previous malignant neoplastic diseases \<5 years prior to enrollment * Evidence of systemic infection at the time of study * HIV, hepatitis C or B virus infection * Aspartate transaminase or alanine transaminase \>2x upper limit of normal, bilirubin \>2.5 times upper limit of normal * Serum creatinine \>1.5 mg/dL or chronic renal disease * Cardiac insufficiency (New York Heart Association scale \>1 or ejection fraction \<50%) * History of transformation from an indolent lymphoma * Pregnancy * History of lactic acidosis or alcoholism
References
Publications (3)
- BACKGROUNDAsensio-Lopez MC, Lax A, Pascual-Figal DA, Valdes M, Sanchez-Mas J. Metformin protects against doxorubicin-induced cardiotoxicity: involvement of the adiponectin cardiac system. Free Radic Biol Med. 2011 Nov 15;51(10):1861-71. doi: 10.1016/j.freeradbiomed.2011.08.015. Epub 2011 Aug 25. PMID 21907790
- BACKGROUNDShi WY, Xiao D, Wang L, Dong LH, Yan ZX, Shen ZX, Chen SJ, Chen Y, Zhao WL. Therapeutic metformin/AMPK activation blocked lymphoma cell growth via inhibition of mTOR pathway and induction of autophagy. Cell Death Dis. 2012 Mar 1;3(3):e275. doi: 10.1038/cddis.2012.13. PMID 22378068
- BACKGROUNDAlkhatib Y, Abdel Rahman Z, Kuriakose P. Clinical impact of metformin in diabetic diffuse large B-cell lymphoma patients: a case-control study. Leuk Lymphoma. 2017 May;58(5):1130-1134. doi: 10.1080/10428194.2016.1239822. Epub 2016 Oct 5. PMID 27701994