A Proof of Concept Pilot Study of the Addition of Venetoclax to Standard Remission Induction Chemotherapy Fludarabine or Cladrabine, Cytarabine, and Granulocyte Colony Stimulating Factor (G-CSF) (FLAG or CLAG) for Frontline Therapy of Secondary Acute Myeloid Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Secondary Acute Myeloid Leukemia
Interventions
DRUG

Venetoclax

Venetoclax administered orally once daily on days 3-16.

DRUG

FLAG or CLAG Protocol

FLAG consists of daily infusions of Fludarabine (30mg/m2/day over 30 minutes) and Ara-C (2g/m2/day over 4 hours) for 5 days with daily subcutaneous injections of G-CSF until count recovery. Tbo-filgrastim will be administered as follows: WBC count \>50,000 - 5mcg/kg; WBC count \<50,000 - hold Tbo-filgrastim. Given the national shortage of Fludarabine, Cladrabine (5mg/m2/day IV over 2 hours) has been substituted (CLAG) with similar toxicity profile.

Trial Locations (1)

48109

RECRUITING

University of Michigan Rogel Cancer Center, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER