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

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2024

Primary Completion Date

April 30, 2025

Study Completion Date

September 30, 2025

Conditions
Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia RefractoryGranulocytic Sarcoma
Interventions
DRUG

CPI 613

"For INDUCTION therapy (14 day cycles): Devimistat (CPI-613) 2,500mg/m2, days 1-5, 14-day cycles for cycles 1 and 2 only.~For MAINTENANCE therapy (21 day cycles): Devimistat (CPI-613) 2,500mg/m2, days 1-5, 21-day cycles until progression, intolerable toxicity or withdrawal of consent."

DRUG

Metformin

"For INDUCTION therapy (14 day cycles):~Metformin 500 mg daily (taken with meals), days 1-2 for cycle 1 only. Metformin 500 mg twice daily (taken with meals), days 3-14 for cycle 1 only. Metformin 1,000 mg daily (taken with meals), days 1-2 for cycle 2 only. Metformin 1,000 mg twice daily (taken with meals) days 3-4 for cycle 2 only.~For MAINTENANCE therapy (21 day cycles): Metformin 1,000 mg twice daily (taken with meals) days 1-21 until progression, intolerable toxicity or withdrawal of consent"

BIOLOGICAL

Blood draws

In the first induction cycle ONLY, extra blood will be withdrawn on day 1 before and after treatment with CPI-613 research purposes. Additional blood draws on days 2-5 to test blood before receiving CPI-613 to make sure participants are healthy enough to receive CPI-613.

PROCEDURE

Bone marrow biopsy

After the second induction cycle participants will have a bone marrow biopsy. After this biopsy, participants will have other bone marrow biopsies every 3 months for the next year. After the first year, participants may have a bone marrow biopsy if the treating physician feels it is necessary.

Sponsors
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Cornerstone Pharmaceuticals

INDUSTRY

lead

Wake Forest University Health Sciences

OTHER

NCT05854966 - CPI-613 Given With Metformin in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) | Biotech Hunter | Biotech Hunter