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

Phase 2 Terminated 10 enrolled University of Michigan Rogel Cancer Center Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine complete remission rate of a novel combination induction chemotherapy treatment based upon 20 patients with newly diagnosed secondary AML.

Timeline

Start: 2024-06-03
Primary completion: 2025-08-16
Completion: 2025-08-16

Outcome

Outcome not reported

Stopped: “Interim Analysis per Protocol”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Venetoclax	Small molecule	—	Oral
Background	Cladrabine	Unknown	5 mg/m2	Intravenous
Background	Cytarabine	Small molecule	2 g	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	filgrastim	Protein / enzyme biologic	5 ug/kg	Subcutaneous

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

Summary

Timeline

Outcome

Drugs

Indications