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Venetoclax + Azacitidine for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
Study Summary
This trial is testing the side effects and best dose of venetoclax when given with azacitidine to treat patients with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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Who is running the clinical trial?
Media Library
- I have CMML or therapy-related MDS that has not responded to treatment.I have side effects from previous cancer treatments that have not fully healed.I have a chronic illness or allergy that may affect my participation in the study.I have hepatitis B or C but my viral load is undetectable.I am a male and will use birth control during and for 3 months after the study.I am pregnant.My MDS is classified as low or intermediate-1 risk.I am HIV positive and aware of potential medication interactions.My white blood cell count is above the required level.I have previously received BCL2 inhibitor therapy.I haven't taken strong or moderate CYP3A inducers in the last 7 days.I cannot take medicine by mouth due to a digestive condition.You have eaten grapefruit, grapefruit products, Seville oranges (including marmalade with Seville oranges), or starfruit in the three days before starting the study treatment.I have had cancer before, but it was either skin cancer, treated cervical or breast cancer in situ, or any cancer treated over 2 years ago.I am taking hydroxyurea to reduce my white cell count before starting venetoclax.I am not pregnant and if capable of becoming pregnant, I agree to use birth control during and for 3 months after the study.I can perform daily activities with minimal assistance.My kidney function is within the required range.My high-risk MDS did not improve after 4 HMA therapy cycles.My heart condition limits my physical activity beyond basic tasks.I have not had a live vaccine in the last 4 weeks.I have a serious infection that is not under control and needs treatment.
- Group 1: Treatment (venetoclax, azacitidine)
- 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.
- 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
Are we still taking participants for this experiment?
"The information available on clinicaltrials.gov indicates that this trial is currently enrolling patients. This study was originally posted on September 4th, 2020, and the most recent update was on July 21st, 2022. This trial is looking for 58 patients at 1 site."
Could you please list the other studies that have used Venetoclax?
"350 clinical trials are currently underway that focus on Venetoclax. 55 of these trials have progressed to Phase 3. Most of the trials for Venetoclax are being conducted in Edmonton, Alberta, but 11240 research sites are testing this treatment."
How many people are eligible to enroll in this study?
"Yes, as the latest update on clinicaltrials.gov shows, this trial is still looking for 58 patients at a single site."
What are some of the things that Venetoclax has been known to help with?
"Venetoclax is a common treatment for induction chemotherapy, but can also be used to help manage refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."
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