BCL2i CLAG-M in R/R Acute Myeloid Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

November 26, 2024

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2027

Conditions
Relapsed or Refractory Acute Myeloid Leukemia (AML)
Interventions
DRUG

Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen

Filgrastim/G-CSF 300 mcg/day for 6 days beginning 24 hours prior to multiagent chemotherapy (days 0-5), cladribine 5 mg/m2 given intravenously over 2 hours for 5 consecutive days (days 1-5), cytarabine given IV over 4 hours for 5 consecutive days (days 1-5) beginning 2 hours after the completion of cladribine, and mitoxantrone 16 mg/m2 given intravenously over 30 minutes for 3 days (days 1-3) after completion of cytarabine.

DRUG

Venetoclax

Venetoclax will be administered orally, once daily, with food.

Trial Locations (2)

33612

RECRUITING

Moffitt Cancer Center, Tampa

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER