Olutasidenib + Venetoclax + Azacitidine for Acute Myeloid Leukemia
(OLUVENAZA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJustin Watts, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Justin Watts, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is as follows: 1. Determine whether people receiving the combination treatment of olutasidenib, venetoclax, and azacitidine have the same, more, or fewer side effects compared to the usual chemotherapy treatment that people with this condition receive. 2. Determine how well the combination treatment of olutasidenib, venetoclax, and azacitidine works compared to the usual chemotherapy treatment that people with this condition receive.

Eligibility Criteria

This trial is for patients with newly diagnosed Acute Myeloid Leukemia (AML) who have a specific mutation called IDH1 and are fit for intensive chemotherapy. The study is open to both adults and children with this type of leukemia.

Inclusion Criteria

My organs are functioning well.

Baseline QT interval corrected using the Fridericia equation (QTcF) ≤ 480 msec

I agree not to donate eggs or sperm during the trial.

+8 more

Exclusion Criteria

Participant plans to become pregnant or father a child while enrolled in this study or within 3 months after last dose of study treatment

My leukemia has spread to my brain or spinal cord.

I am between 18 and 75 years old.

+14 more

Participant Groups

The study tests a combination treatment using three drugs: Olutasidenib, Venetoclax, and Azacitidine. It aims to compare the effectiveness and side effects of this regimen against standard chemotherapy treatments for AML.

1Treatment groups

Experimental Treatment

Group I: OLUVENAZA Treatment GroupExperimental Treatment3 Interventions

Participants in this group will receive combination treatment of Olutasidenib, Venetoclax and Azacitidine orally for up to 12 cycles, each cycle lasting 28 days. Total participation duration is about 14 months