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RECRUITING
NCT03214562
PHASE1/PHASE2

Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.

Official title: A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2017-09-26

Completion Date

2027-09-30

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

Cytarabine

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine

Given IV

DRUG

Idarubicin

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

DRUG

Venetoclax

Given PO

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States