TerminatedPhase 1

Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML

Stopped: Slow accrual

United States2 participantsStarted 2015-03-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with relapsed/refractory disease must have morphologic proof (from bone marrow aspirate, smears or touch preps of bone marrow biopsy) of AML with \>= 10% blasts within two weeks (14 days) prior to initiation of therapy * All immunophenotype and cytogenetic/molecular groups are eligible for participation except for acute promyelocytic leukemia (APL) (as proven by the presence of promyelocytic leukemia/retinoic acid receptor alpha \[PML-RARα\]) * Patients must demonstrate one of the following: * Relapse after first complete remission * Refractory to conventional induction chemotherapy (failure to respond to 1 or more cycles of daunorubicin and cytarabine) or to re-induction * Patients with previously untreated AML are candidates if they are unable to receive anthracyclines, and have documented AML with \>= 20% blasts within one week prior to enrollment * Patients with chronic myelogenous leukemia (CML) in myeloid blast crisis are eligible if their disease has failed to respond, and/or they are intolerant, to the available tyrosine kinase inhibitors (TKIs) * Serum total and direct bilirubin =\< upper limit of normal (ULN) * Serum creatinine \< 1.4 mg/dl in females and \< 1.5 mg/dl in males, and creatinine clearance \> 60 mL/min * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\])/serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< ULN * Bicarbonate within the normal range of t…

What they're measuring

Evaluate Toxicity by Assessing the Adverse Events of Metformin and Cytarabine

Timeframe: Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)

Study Treatment Dose Toxicity Will be Evaluated by Measurement of Adverse Events Experienced While on Treatment

Timeframe: Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)

Trial details

NCT IDNCT01849276

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01-21

Results submitted2018-04-12

View on ClinicalTrials.gov More Adult Acute Megakaryoblastic Leukemia (M7) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evaluate Toxicity by Assessing the Adverse Events of Metformin and Cytarabine

Timeframe: Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)

Study Treatment Dose Toxicity Will be Evaluated by Measurement of Adverse Events Experienced While on Treatment

Timeframe: Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)