Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy for patients with newly diagnosed diffuse large-B cell lymphoma
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Potentially increasing the efficacy and safety of standard chemotherapy through several mechanisms
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico
Incidence of treatment-emergent adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Response rates
Overall, partial and complete responses to chemoimmunotherapy
Time frame: 6 months
Progression-free survival
Survival with freedom from progression
Time frame: 2-5 years
Overall survival
Survival from diagnosis until death or last follow-up
Time frame: 2-5 years
Event-free survival
Survival from diagnosis until death or progression
Time frame: 2-5 years
Time to progression or relapse
Time from diagnosis until disease progression or relapse
Time frame: 2-5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.