Rituximab, Cyclophosphamide, Vincristine and Prednisone (R-CHOP) Plus Metformin in Diffuse Large-B-cell Lymphoma

Phase 2

Completed

Brief Summary: Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy for patients with newly diagnosed diffuse large-B cell lymphoma

Detailed Description: Patients with newly diagnosed diffuse large-B cell non Hodgkin lymphoma, irrespective of cell of origin status will receive metformin in combination to Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (RCHOP) chemotherapy for 6 cycles, until response evaluation as reported elsewhere:

1.- Rituximab 375 mg/m2 IV, day 1. 2.- Cyclophosphamide 750 mg/m2 IV, day 1. 3.- Doxorubicin 50 mg/m2 IV day 1. 4.- Vincristine 1.4 mg/m2 IV (2 mg maximum dose). 5.- Prednisone 60 mg/m2 PO days 1-5. Six cycles every 21 days.

Metformin will be added and administered in an outpatient basis, starting with 425 mg twice a day for 1 week, followed by 850 mg twice a day for 1 week, and lastly 850 mg every 8 hours maximum dose until re-staging. Laboratory tests will be performed serially.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Metformin arm	Metformin	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)

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	6 months	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Response rates	6 months	Overall, partial and complete responses to chemoimmunotherapy

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	2-5 years	Survival with freedom from progression
Overall survival	2-5 years	Survival from diagnosis until death or last follow-up
Event-free survival	2-5 years	Survival from diagnosis until death or progression
Time to progression or relapse	2-5 years	Time from diagnosis until disease progression or relapse

Locations (1): Hospital Universitario Dr. José Eleuterio González
🇲🇽
Monterrey, Nuevo Leon, Mexico

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