drugset / Trial / NCT01849276
Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to determine if metformin in combination with cytarabine is safe and effective. Participants in this research study have acute myeloid leukemia (AML) that has come back after initial treatment or has not gone away with initial therapy.There is evidence that metformin directly kills leukemia cells. Laboratory data have also shown that combinations of metformin with cytarabine are more efficient than each agent alone in killing leukemia cells in the laboratory.
Timeline
- Start
- 2015-03-11
- Primary completion
- 2016-01-21
- Completion
- 2016-01-21
Outcome
Outcome not reported
Stopped (Enrollment): “Slow accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | — | Oral |
| Background | Cytarabine | Small molecule | — | Intravenous |
Indications
acute erythroid leukemia
acute megakaryoblastic leukemia in adult
acute myeloblastic leukemia with maturation
acute myeloblastic leukemia without maturation
acute myeloid leukemia with 11q23 abnormalities
acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22)
acute myeloid leukemia with minimal differentiation
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, del(5q31-q32)
acute myeloid leukemia, t(16;16)(p13.1;q22)
acute myelomonocytic leukemia M4
adult acute monocytic leukemia
blast phase chronic myelogenous leukemia, BCR-ABL1 positive