IDH Mutant Targeted Therapies + Azacitidine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+114 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Celgene

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study are 1. to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and, 2. to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.

Eligibility Criteria

This trial is for adults with a new diagnosis of acute myeloid leukemia (AML) that has IDH mutations and can't handle strong chemotherapy. They should be able to undergo regular bone marrow tests, have an ECOG performance status of 0-2, and not have had previous IDH-targeted treatments or certain types of AML.

Inclusion Criteria

I have been diagnosed with AML with more than 20% cancer cells in my bone marrow.

I can take care of myself and am up and about more than half of my waking hours.

I agree to have multiple bone marrow tests.

Exclusion Criteria

My AML developed from chronic myelogenous leukemia.

I might have leukemia affecting my brain or spinal cord.

There are other requirements or restrictions for participating in the study that are specified in the study protocol.

+2 more

Participant Groups

The study is testing the safety and effectiveness of two drug combinations: AG-120 plus Azacitidine, and AG-221 plus Azacitidine. It aims to find the best doses when used together and compare them against using Azacitidine alone in treating AML with specific genetic changes.

3Treatment groups

Experimental Treatment

Group I: AzacitidineExperimental Treatment1 Intervention

Group II: AG-221 + AzacitidineExperimental Treatment2 Interventions

Group III: AG-120 + AzacitidineExperimental Treatment2 Interventions

AG-120 is already approved in United States for the following indications:

🇺🇸 Approved in United States as Tibsovo for: