Spots Global Cancer Trial Database for CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

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Trial Identification

Brief Title: CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Official Title: An Open Label, Pilot Phase II Study to Evaluate the Feasibility and Efficacy of CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Study ID: NCT05854966

Conditions

Acute Myeloid Leukemia, in Relapse

Acute Myeloid Leukemia Refractory

Granulocytic Sarcoma

Interventions

Study Description

Brief Summary: The purpose of this research study is to find out what effects (the good and bad) the combination treatment of metformin and CPI-613 has in treating participants with acute myeloid leukemia or granulocytic sarcoma that has either returned after treatment or did not respond to treatment.

Detailed Description: Primary Objective: To establish the feasibility of delivering the combination of CPI-613 and metformin in patients with relapsed or refractory acute myeloid leukemia (AML). Secondary Objectives: To determine the response rate of CPI-613 and metformin in relapsed or refractory AML defined as Complete remission (CR) + Complete remission with incomplete count recovery (CRi) + Morphologic Leukemia-Free State (MLFS). * To determine the overall survival of patients with relapsed or refractory AML treated with CPI-613 and metformin. * To determine the safety of CPI-613 and metformin in patients with relapsed or refractory acute myeloid leukemia (AML).