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IO-202 + Azacitidine/Venetoclax for AML and CMML
Study Summary
This trial is testing a new drug for people with relapsed or refractory AML with monocytic differentiation and CMML. They are trying to find the best dose of the new drug.
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.Trial Design
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Who is running the clinical trial?
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- I have CMML and have never been treated with hypomethylating agents.I have AML that didn't respond to treatment and fits specific types.I currently have an active infection.I have CMML that didn't respond to treatment or has come back.I have a serious heart rhythm problem.I am willing to undergo repeated bone marrow tests and blood sampling for the study.I am newly diagnosed with AML and cannot undergo standard treatment.I do not have any uncontrolled, active infections.A potentially curative treatment is available for my cancer.I haven't taken any calcineurin inhibitors for at least 4 weeks.I do not have active, uncontrolled leukemia in my brain or spinal cord.I have a specific type of leukemia (APL, Ph+ AML, or CML in blast crisis).I have severe, life-threatening complications from leukemia.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I haven't had cancer treatment or radiation in the last 7 days, except for Hydroxyurea or leukapheresis.My AML has returned or didn't respond to treatment, and it's a specific type with high LILRB4.My kidneys are working well.I have lung issues like scarring or inflammation.My liver is working well.I have an active cancer diagnosis.I have recovered from side effects of my previous cancer treatments.I had a stem cell transplant less than 60 days before starting IO-202.I take more than 10 mg of prednisone or its equivalent daily.My heart's pumping ability is significantly reduced.I am a woman who can have children and have a recent negative pregnancy test.I have received a treatment targeting LILRB4 before.I have not received a donor lymphocyte infusion in the last 30 days.I can understand and am willing to sign the consent form myself, or I have someone legally authorized to do so on my behalf.
- Group 1: Dose Expansion of IO-202 plus Azacitidine AML
- Group 2: Dose Expansion of IO-202 plus Azacitidine CMML
- Group 3: Dose Expansion of IO-202 plus Azacitidine + Venetoclax (Ven)
- Group 4: Dose Escalation of IO-202 Plus Azacitidine
- Group 5: Dose Escalation of IO-202
- 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.
- 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
Could you elaborate on the potential hazards of IO-202?
"Limited safety and efficacy data for IO-202 warrants a score of 1 on our team's assessment scale. As this is a Phase 1 trial, the risks associated with participating are relatively high."
What primary goals has this experiment been designed to accomplish?
"The primary goal of this medical experiment, which will be observed from the first dose to 30 days following the last treatment instance, is assessing safety as indicated by adverse events. Secondary objectives include quantifying IO-202's PK through AUC measurement, gauging response rates in patients with anti-drug antibodies, and determining Cmax for IO-202."
In what geographical locations is this experiment taking place?
"The list of medical centres offering this clinical trial are numerous. Winship Cancer Institute at Emory University in Atlanta, the University of California San Francisco and Davis, as well as other twelve sites across the nation all provide access to this treatment."
Are there still opportunities for individuals to participate in this experiment?
"The trial, initially posted on September 14th 2020 and last revised on May 3rd 2022, is still seeking participants. This fact can be confirmed by visiting clinicaltrials.gov."
What is the maximum number of individuals eligible for this experiment?
"Affirmative. According to clinicaltrials.gov, the research in question is currently seeking volunteers and opened recruitment on September 14th 2020. As of May 3rd 2022, 119 participants need to be recruited at a dozen different sites for this study."
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