Diffuse Large B Cell Lymphoma
Conditions
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.
Interventions
DRUGMetformin
Potentially increasing the efficacy and safety of standard chemotherapy through several mechanisms
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed