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

• Status: Unknown status
• Trial end date: 2019-01-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Treatments: Metformin

Criteria

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