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Monoclonal Antibodies
Magrolimab Combinations for Myeloid Leukemia
Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 75 years of age
Individuals with LVEF > 50%, lack of symptomatic congestive heart failure, or clinically significant cardiac arrhythmias
Timeline
Screening 3 weeks
Treatment Varies
Follow Up safety run-in cohorts 1 and 2: first dose date up to 3 years; safety run-in cohort 3: first dose date up to 5 years; phase 2 cohorts 1 and 2: first dose date up to 3 years; phase 2 cohort 3: first dose date up to 5 years
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of a new drug, magrolimab, in combination with existing treatments for acute myeloid leukemia. The study will determine the best dose of magrolimab to use and whether the combination treatment is more effective than existing treatments alone.
Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) who can't have standard treatment due to age or health issues, or those who've relapsed after initial therapy. Participants need good heart and kidney function, agree to use contraception if applicable, and be willing to undergo bone marrow biopsies. Excluded are pregnant or breastfeeding women, those with hypersensitivity to study drugs, recent live vaccines, bleeding disorders, CNS AML involvement, certain other cancers or serious medical conditions.Check my eligibility
What is being tested?
The study tests the safety and dosing of magrolimab in combination with anti-leukemia therapies like Venetoclax and Azacitidine among others. It aims at finding effective treatments for different groups: newly diagnosed unfit patients; those whose AML returned after treatment; and as a maintenance therapy post-chemo.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as allergies or infusion-related symptoms. There could also be effects on blood cells leading to increased risk of infections or bleeding. Organ-specific inflammation might occur along with general symptoms like fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 75 years old or older.
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My heart functions well, with no failure or significant irregular beats.
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I have AML, am in remission but still have some cancer cells, and can't have a stem cell transplant within a year.
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My kidney function, measured by creatinine clearance, is below 45 mL/min.
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I have not reached the maximum safe dose of certain chemotherapy drugs.
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You have newly diagnosed acute myeloid leukemia (AML) and are unable to receive standard chemotherapy due to age or medical conditions. You have not received certain previous treatments and have specific health conditions that allow for enteral administration of the study drug. You must also meet certain performance status and heart function criteria.
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I need some help with daily activities due to my health condition.
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I do not have brain damage from diseases or chemicals.
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My hemoglobin level is at least 9 g/dL before starting the study treatment.
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I have AML and can't undergo standard treatment due to my age or health issues.
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I can take medications by mouth without issues.
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I agree to use birth control as required by the study.
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My heart's pumping ability is reduced.
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I can care for myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ safety run-in cohorts 1 and 2: first dose date up to 3 years; safety run-in cohort 3: first dose date up to 5 years; phase 2 cohorts 1 and 2: first dose date up to 3 years; phase 2 cohort 3: first dose date up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety run-in cohorts 1 and 2: first dose date up to 3 years; safety run-in cohort 3: first dose date up to 5 years; phase 2 cohorts 1 and 2: first dose date up to 3 years; phase 2 cohort 3: first dose date up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimal Residual Disease Negative Complete Remission Rate (Phase 2 Cohort 3)
Mutagenicity Tests
Therapeutic procedure
+2 moreSecondary outcome measures
Complete Remission or Complete Remission with Partial Hematologic Recovery Rate (Safety Run-in Cohorts 1 and 2; Phase 2 Cohorts 1 and 2)
Duration of Complete Remission (Safety Run-in Cohorts 1 and 2; Phase 2 Cohorts 1 and 2)
Duration of Complete Remission or Complete Remission with Incomplete Hematologic Recovery (Safety Run-in Cohorts 1 and 2; Phase 2 Cohorts 1 and 2)
+15 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Safety Run-in Cohort 3 (Post-Chemo Maintenance Mag+CC-486)Experimental Treatment2 Interventions
Participants with newly diagnosed AML who are in complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) with minimal residual disease (MRD) positivity following intensive chemotherapy will receive magrolimab and CC-486.
Group II: Safety Run-in Cohort 2 (R/R AML Mag+MEC)Experimental Treatment4 Interventions
Participants with relapsed or refractory (r/r) AML will receive magrolimab and MEC.
Group III: Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza)Experimental Treatment3 Interventions
Participants with newly diagnosed untreated AML who are ineligible for intensive induction chemotherapy will receive magrolimab, venetoclax and azacitidine.
Group IV: Phase 2 Cohort 3 (Post-Chemo Maintenance Mag+CC-486)Experimental Treatment2 Interventions
Participants with newly diagnosed AML who are in complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) with minimal residual disease (MRD) positivity following intensive chemotherapy will receive magrolimab at the RP2D determined in the Safety run-in cohort 3 and CC-486.
Group V: Phase 2 Cohort 2 (R/R AML Mag+MEC)Experimental Treatment4 Interventions
Participants with relapsed or refractory (r/r) AML will receive magrolimab at the RP2D determined in the Safety run-in cohort 2 and MEC.
Group VI: Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza)Experimental Treatment3 Interventions
Participants with newly diagnosed untreated AML who are ineligible for intensive induction chemotherapy will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety run-in cohort 1, venetoclax and azacitidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Azacitidine
2012
Completed Phase 3
~1440
Mitoxantrone
2008
Completed Phase 3
~1510
CC-486
2015
Completed Phase 2
~630
Venetoclax
2019
Completed Phase 3
~1990
Cytarabine
2016
Completed Phase 3
~3310
Magrolimab
2021
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,699 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,693 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine clearance, is below 45 mL/min.I have been diagnosed with acute promyelocytic leukemia.I haven't had a bone marrow transplant in the last 100 days and am not on immunosuppressants.I am 75 years old or older.I have not received a live virus vaccine in the last 4 weeks.My heart functions well, with no failure or significant irregular beats.I've been on maintenance therapy for over a year with no signs of active cancer.I haven't been treated with trastuzumab in the last 7 months.I have AML, am in remission but still have some cancer cells, and can't have a stem cell transplant within a year.My leukemia is suspected to or has spread to my brain or spinal cord.I am between 18 and 74 years old and have at least one serious health condition.I have had cancer before, but it's been inactive for over a year, except for certain types like skin or prostate cancer.I have not reached the maximum safe dose of certain chemotherapy drugs.My liver is working well.You have newly diagnosed acute myeloid leukemia (AML) and are unable to receive standard chemotherapy due to age or medical conditions. You have not received certain previous treatments and have specific health conditions that allow for enteral administration of the study drug. You must also meet certain performance status and heart function criteria.I need some help with daily activities due to my health condition.I do not have brain damage from diseases or chemicals.I have been treated with drugs targeting CD47 or SIRPα.My kidneys are working well.I haven't eaten grapefruit, Seville oranges, or starfruit in the last 3 days.My hemoglobin level is at least 9 g/dL before starting the study treatment.I have AML and haven't had specific anti-leukemia treatments, except possibly hydroxyurea or oral etoposide.I have AML and can't undergo standard treatment due to my age or health issues.I am part of the post-chemo maintenance group with specific treatments.I have a known bleeding disorder.I have an active or chronic hepatitis B or C infection, or HIV.I can take medications by mouth without issues.My AML did not respond or returned after my first intense chemotherapy.It's been over 2 weeks since my last leukemia treatment, excluding certain medications and local radiotherapy.I agree to use birth control as required by the study.I am currently breastfeeding.I agree to use birth control as required by the study.My heart's pumping ability is reduced.I haven't taken strong medications like St. John's Wort in the last week.I can care for myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Cohort 2 (R/R AML Mag+MEC)
- Group 2: Phase 2 Cohort 3 (Post-Chemo Maintenance Mag+CC-486)
- Group 3: Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza)
- Group 4: Safety Run-in Cohort 2 (R/R AML Mag+MEC)
- Group 5: Safety Run-in Cohort 3 (Post-Chemo Maintenance Mag+CC-486)
- Group 6: Phase 2 Cohort 1 (1L Unfit AML Mag+Ven+Aza)
Awards:
This trial has 1 awards, including:- 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.
What is the cumulative enrollment count of this trial?
"At the moment, this trial is not accepting new participants. It was posted on June 28th 2021 and last updated November 21st 2022. If you're seeking other studies to join, there are 2382 cancer-related trials open for enrollment right now as well as 805 CC-486 opportunities in existence presently."
Answered by AI
Could you provide an exhaustive list of investigations that have centered around CC-486?
"Currently, 805 clinical trials are researching the efficacy of CC-486 with 177 in Phase 3. While most studies for this treatment take place in Edmonton, Alberta, there is a total of 31190 sites worldwide running these medical experiments."
Answered by AI
What are the common applications of CC-486?
"CC-486 can be employed to manage cases of anemia, multiple sclerosis, and even merkel cell cancer."
Answered by AI
Has CC-486 received the necessary authorization from the FDA?
"Based off the available data, CC-486 has been estimated to have a safety rating of 2. This is because it is currently in Phase 2 trials and only preliminary findings regarding its safety are known at this time."
Answered by AI
Are any new participants being welcomed into this research project?
"Unfortunately, this clinical trial has already finished recruiting patients. It was initially published on June 28th 2021 and stopped accepting applications after November 21st 2022. However, if you are looking to become involved in other studies there are currently 2382 cancer-related trials and 805 involving CC-486 that remain open for enrollment."
Answered by AI
What are the main aims of this research project?
"Per the trial sponsor, Gilead Sciences, this experiment's primary outcome is an assessment of Rate of Complete Remission (CR) or Complete Remission with Incomplete Hematologic Recovery (CRi), to be evaluated during the first 28 days post dosing. Secondary outcomes include gathering data on Treatment-emergent Adverse Events (TEAEs), Duration of Minimal Residual Disease Negative CR/CRi status and completion rate for MRD negative complete remission responses."
Answered by AI
Are there any Canadian medical facilities currently conducting this experiment?
"The current trial is being conducted in 17 different health centres, including Cleveland, Buffalo and Dallas. For those considering participation, it is advised to choose the nearest clinic to reduce necessary travel."
Answered by AI
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