NCT01849276

Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML

A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of metformin (metformin hydrochloride) in combination with cytarabine in relapsed/refractory AML. II. Define the dose limiting toxicity (DLT) of metformin in combination with cytarabine in relapsed/refractory AML. SECONDARY OBJECTIVES: I. Remission rate. II. Overall survival (OS). III. Disease-free survival (DFS). IV. Length of remission. OUTLINE: This is a dose-escalation study of metformin hydrochloride in combination with Cytarabine. Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-15 and cytarabine intravenously (IV) over 3 hours BID on days 4-10. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.

Conditions

• Adult Acute Megakaryoblastic Leukemia (M7)
• Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
• Adult Acute Monoblastic Leukemia (M5a)
• Adult Acute Monocytic Leukemia (M5b)
• Adult Acute Myeloblastic Leukemia With Maturation (M2)
• Adult Acute Myeloblastic Leukemia Without Maturation (M1)
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Adult Acute Myelomonocytic Leukemia (M4)
• Adult Erythroleukemia (M6a)
• Adult Pure Erythroid Leukemia (M6b)
• Blastic Phase Chronic Myelogenous Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	metformin hydrochloride	Given orally
DRUG	cytarabine	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-03-11
• Primary completion: 2016-01-21
• Completion: 2016-01-21
• First posted: 2013-05-08
• Last updated: 2019-01-31
• Results posted: 2018-11-13

Locations

1 site across 1 country: United States