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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
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 belowSelect...
I am 18 or older with AML in my first remission and not ready for a stem cell transplant.
Select...
I am capable of limited self-care and spend more than half of my waking hours out of bed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
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 moreTrial 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
13,695 Previous Clinical Trials
40,929,737 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,980 Previous Clinical Trials
1,789,793 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,003 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control or abstain from sex during and 30 days after treatment.I have an active brain or spinal cord disease.My bone marrow functions well.I have been diagnosed with a specific type of leukemia (APL or AML-M3).I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I can understand and agree to the study's terms.I can join the study at any time if my cancer is still detectable after initial treatment.My organs are functioning well.I am 18 or older with AML in my first remission and not ready for a stem cell transplant.I am not pregnant, breastfeeding, or planning to become pregnant during the study.I have AML with specific genetic changes and can't or won't take certain medications.I am willing to leave my current trial to join a new one.I am a woman of childbearing age and agree to follow specific precautions.I've had intensive therapy for my cancer and am not more than 2 months post my last treatment.I've had at least 2 rounds of mild treatment for my cancer and am now in remission.I have AML without a history of it spreading outside the bone marrow, except for controlled CNS involvement.I am capable of limited self-care and spend more than half of my waking hours out of bed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (azacytidine, venetoclax)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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