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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
For male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
Adequate BM reserve:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 agree to use birth control or abstain from sex during and 30 days after treatment.
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My bone marrow functions well.
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I can understand and agree to the study's terms.
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I can join the study at any time if my cancer is still detectable after initial treatment.
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My organs are functioning well.
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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 a woman of childbearing age and agree to follow specific precautions.
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I've had intensive therapy for my cancer and am not more than 2 months post my last treatment.
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I've had at least 2 rounds of mild treatment for my cancer and am now in remission.
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I am capable of limited self-care and spend more than half of my waking hours out of bed.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse-free survival (RFS)
Secondary outcome measures
Complete remission duration (CRd)
Event free survival (EFS)
Incidence of toxicity
+2 more

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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,297 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,306 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,703 Total Patients Enrolled

Media Library

Azacitidine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04062266 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (azacytidine, venetoclax)
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04062266 — Phase 2
Azacitidine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04062266 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are sign ups for this clinical trial?

"The data available on clinicaltrials.gov does show that this particular trial is currently looking for test subjects. This specific study was originally posted on September 13th, 2019 with the most recent update taking place on September 19th, 2020. The investigators running the trial are seeking 50 individuals from a single medical facility."

Answered by AI

Can you please tell me what other research has been conducted using Azacitidine?

"350 clinical trials are researching azacitidine with 55 of those in Phase 3. 11282 research sites are studying this treatment for efficacy, many of which are based in Edmonton, Alberta."

Answered by AI

Has Azacitidine been cleared by the FDA?

"Azacitidine is still being studied in Phase 2 clinical trials, so there is not enough information to support its efficacy. However, the data that has been collected thus far indicates that it is a safe medication."

Answered by AI

For what sorts of illnesses is azacitidine commonly prescribed?

"Azacitidine is a useful medication for induction chemotherapy and treating other conditions such as refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."

Answered by AI

Are patients being signed up for this experiment currently?

"That is correct. The information available on clinicaltrials.gov indicates that the trial is still looking for participants. This study was originally posted on September 13th, 2019 and has since been updated on September 19th, 2020. They are hoping to find 50 patients from 1 site total."

Answered by AI
~30 spots leftby Oct 2030