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Triple-Drug Therapy for Acute Myeloid Leukemia
Study Summary
This trial is testing magrolimab, azacitidine, and venetoclax to treat acute myeloid leukemia. Magrolimab is an antibody that may stop cancer cells from growing. Azacitidine and venetoclax are chemotherapy drugs that work in different ways to stop the growth of cancer cells. Giving all three drugs may help to control the disease.
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 2007 Phase 3 trial • 358 Patients • NCT00071799Trial Design
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- I have been diagnosed with AML, not including APL.I agree to use birth control during the study and for 4 months (women) or 3 months (men) after.I am willing and able to follow the study's requirements.I do not have an active infection or fever from an infection in the last 2 days.I am 18 or older with AML that has come back or didn't respond to treatment, and I can't or won't undergo potentially curative therapy. I've had up to 2 treatments for AML.I do not have any severe or uncontrolled medical conditions.I am not able to have children, am postmenopausal, or have a negative pregnancy test.I haven't had an organ transplant in the last 3 months, don't have severe GVHD, or need immunosuppression due to a transplant.I have not had any major surgery in the last 14 days.I have not received chemotherapy but may have had transfusions or vitamins for a blood disorder.My liver enzymes are within the acceptable range set by my doctor.It's been at least 2 weeks or 5 half-lives since my last treatment, and I've recovered from its side effects.I am 18 or older with AML that has come back or didn't respond to treatment, have had 1-2 treatments, can care for myself, and haven't used venetoclax.My kidney function, measured by creatinine clearance, is adequate.I am 18 or older with a specific type of high-risk AML.I have been treated with a CD47 or SIRPalpha targeting agent before.I am 75 or older with new AML and can't have strong chemotherapy due to my age or health issues.I have leukemia in my brain that is causing symptoms or is not well-controlled.You cannot have eaten grapefruit, Seville oranges, or starfruit within 3 days before starting the study treatment.I have had up to 2 treatments for my acute myeloid leukemia.I am 18 or older with AML that has come back or didn’t respond to treatment, and I can't or won't undergo potentially curative therapy but have had at least one prior treatment.I am not allergic to magrolimab, venetoclax, or azacitidine.I do not have any severe health conditions that could worsen by joining this study.I have a known bleeding disorder.I can take care of myself but might not be able to do heavy physical work.I am currently receiving treatment for brain disease prevention or control.
- Group 1: Treatment (azacitidine, venetoclax, magrolimab)
- 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 there any open vacancies for individuals to take part in this research program?
"Affirmative. Based on the information available on clinicaltrials.gov, this medical study is actively searching for participants. Initially posted on July 28th 2020 and most recently updated March 8th 2023, the research requires 98 patients to be recruited from a single location."
What therapeutic benefits does Azacitidine offer?
"Azacitidine is commonly used to treat induction chemotherapy, however it may also be beneficial for refractory anemias, acute myeloid leukemia and multi-lineage dysplasia."
Are there any previous investigations involving the drug Azacitidine?
"Presently, 340 trials researching Azacitidine are ongoing with 52 of them in their terminal phase. While a majority of these clinical investigations are conducted in Edmonton, Alberta, there is also activity across the globe at 11923 sites."
How many participants are included in the evaluation of this clinical trial?
"Affirmative. The records on clinicaltrials.gov state that this research is actively seeking participants, having been first unveiled on July 28th 2020 and recently updated on March 8th 2023. Currently, the project requires 98 volunteers across 1 location."
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