RecruitingPhase 1Phase 2NCT03471260

Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies

Phase Ib/II Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +/- Azacitidine in IDH1-Mutated Hematologic Malignancies


Sponsor

M.D. Anderson Cancer Center

Enrollment

96 participants

Start Date

Mar 19, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — ivosidenib, venetoclax, and sometimes azacitidine — in patients with blood cancers (like AML or MDS) that carry a specific genetic mutation called IDH1, to see if the combination can achieve or improve remission. **You may be eligible if...** - You are over 18 years old - Your cancer has the IDH1-R132 genetic mutation (found through lab testing) - You have relapsed or treatment-resistant AML (acute myeloid leukemia), OR you have newly diagnosed AML but cannot tolerate standard intensive chemotherapy, OR you have high-risk MDS or related bone marrow disorders that have not responded to other therapy - Your liver and kidney function are within acceptable ranges **You may NOT be eligible if...** - You are allergic to ivosidenib or venetoclax - You have previously received either of these two drugs - You have active, uncontrolled infections or serious psychiatric illness - You have active graft-versus-host disease (GVHD) following a prior stem cell transplant - You are currently taking strong CYP3A enzyme-interacting medications (certain antibiotics, antifungals, anticonvulsants) 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

DRUGAzacitidine

Given IV or SC

DRUGIvosidenib

Given PO

DRUGVenetoclax

Given PO


Locations(4)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03471260


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