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Anti-metabolites

Azacitidine + Venetoclax for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Tapan M Kadia

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged >/= 18 years AML who have achieved their FIRST CR or CRi and are not immediately candidates for allogeneic stem cell transplant.

ECOG performance status of < or = 3

Must not have

Patients with active CNS (central nervous system) disease.

Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by FAB classification based on morphology, immunophenotype, molecular, or cytogenetic s studies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will study how well azacitidine and venetoclax work in treating patients with acute myeloid leukemia.

Who is the study for?

This trial is for adults over 18 with Acute Myeloid Leukemia (AML) in their first remission who aren't going for a stem cell transplant right away. They must have finished induction therapy and at least one consolidation cycle if they had intensive treatment, or two cycles of lower intensity therapy. Participants need to be healthy enough overall, not pregnant or breastfeeding, willing to use contraception, and without certain other serious illnesses.

What is being tested?

The study is testing the effectiveness of azacitidine combined with venetoclax as maintenance therapy for AML patients in remission. It aims to see how these chemotherapy drugs work together to prevent cancer cells from growing by killing them or stopping their division and spread.

What are the potential side effects?

Azacitidine and Venetoclax can cause side effects like nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems, fatigue, liver issues, kidney function changes and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with AML in my first remission and not ready for a stem cell transplant.

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I am capable of limited self-care and spend more than half of my waking hours out of bed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active brain or spinal cord disease.

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I have been diagnosed with a specific type of leukemia (APL or AML-M3).

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I have AML without a history of it spreading outside the bone marrow, except for controlled CNS involvement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse-free survival (RFS)

Secondary study objectives

Complete remission duration (CRd)

Event free survival (EFS)

Incidence of toxicity

+2 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (azacytidine, venetoclax)Experimental Treatment2 Interventions

Patients receive azacitidine SC or IV over 1 hour daily on days 1-5, and venetoclax PO daily on days 1-14. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

FDA approved

Venetoclax

FDA approved

0 / 7Eligibility criteria met