RecruitingPhase 1Phase 2NCT03214562

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

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

116 participants

Start Date

Sep 26, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding venetoclax (a drug that helps cancer cells die) to standard intensive chemotherapy improves outcomes for patients with acute myeloid leukemia (AML) — a fast-growing blood cancer. **You may be eligible if...** - You have been diagnosed with AML or high-risk myelodysplastic syndrome (MDS, a bone marrow disorder with at least 10% abnormal cells) - You are either newly diagnosed OR your AML has come back or has not responded to prior treatment - Your general health is good enough to receive intensive chemotherapy (ECOG score of 0, 1, or 2) - If you are over 65, your doctor and the study team have determined you are healthy enough for intensive treatment **You may NOT be eligible if...** - Your general health is too poor for intensive chemotherapy - You have uncontrolled infections or other conditions making treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCytarabine

Given IV

BIOLOGICALFilgrastim

Given SC

DRUGFludarabine

Given IV

DRUGIdarubicin

Given IV

BIOLOGICALPegfilgrastim

Given SC

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03214562


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