18 and older, any sex, with Adult Acute Megakaryoblastic Leukemia (M7) or Adult Acute Minimally Differentiated Myeloid Leukemia (M0). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluate Toxicity by Assessing the Adverse Events of Metformin and CytarabinePrimary· Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)
To determine the maximum tolerated dose (MTD) by assessing the adverse events of metformin in combination with cytarabine in evaluating toxicity. Assessments will occur daily during cytarabine administration and at least twice weekly following treatment until blood count recovery.
Grade 1
Group
Value
95% CI
Treatment (Enzyme Inhibitor and Chemotherapy)
4
Grade 2
Group
Value
95% CI
Treatment (Enzyme Inhibitor and Chemotherapy)
6
Grade 3
Group
Value
95% CI
Treatment (Enzyme Inhibitor and Chemotherapy)
2
Grade 4
Group
Value
95% CI
Treatment (Enzyme Inhibitor and Chemotherapy)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collect cover a 7 month period before the study was terminated early due to slow accrual.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04621669 — Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride
· Phase 1
· unknown
NCT04218734 — A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM
· Phase 3
· completed
NCT02153450 — Stereotactic Radiosurgery and Metformin in Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer
· EARLY_PHASE1
· completed
NCT02122185 — Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
· Phase 2
· completed
NCT01793948 — Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer
· EARLY_PHASE1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 31 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01849276.