Venetoclax + Azacitidine for Leukemia

Recruiting in Palo Alto (17 mi)

Dan Pollyea, MD, MS | Profiles | School ...

Overseen byDaniel Pollyea, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study aims to treat non-elderly adult patients, who were previously untreated for acute myeloid leukemia, using venetoclax and azacitidine.

Eligibility Criteria

Adults aged 18-59 with newly diagnosed acute myeloid leukemia (AML) who haven't been treated before can join. They should be in relatively good health, with an ECOG score of ≤2, and have normal liver and kidney function. Men must use contraception; women not post-menopausal or without a hysterectomy/oophorectomy must use two forms of birth control or abstain from sex.

Inclusion Criteria

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

I will use birth control from the start of the study drug until 90 days after the last dose.

I am a pre-menopausal woman who agrees to use two forms of birth control or abstain from sex.

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Exclusion Criteria

I have been treated for MDS or AML, but ATRA for suspected APL doesn't disqualify me.

I cannot take medicine by mouth due to a digestive condition.

I am currently being treated for a serious infection that is not under control.

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Participant Groups

The trial is testing the combination of two drugs, Venetoclax and Azacitidine, as a treatment for AML in non-elderly adults. It's aimed at those who are newly diagnosed and have not received any prior treatments for their condition.

1Treatment groups

Experimental Treatment

Group I: Azacitidine and VenetoclaxExperimental Treatment2 Interventions

Azacitidine will be given intravenously for 7 days. Venetoclax will be given orally. The patient will start out with 100mg and progress to 600mg. Once 600mg is reached, the patient will stay at this dose until the 28 day cycle is finished.

Azacitidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Vidaza for: