Your session is about to expire
← Back to Search
Magrolimab + Azacitidine for AML/MDS After Stem Cell Transplant
Phase 1
Waitlist Available
Led By Monzr M Al Malki
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed up to 6 years
Awards & highlights
Study Summary
This trial studies a combo of drugs to treat high risk acute myeloid leukemia/myelodysplastic syndromes after stem cell transplant using an antibody to block CD47 to help body's immune system destroy cancer cells.
Who is the study for?
This trial is for adults aged 18-75 with high-risk acute myeloid leukemia or myelodysplastic syndrome, who are undergoing their first or second donor stem cell transplant. Participants must have proper liver and kidney function, a certain level of blood cells, and agree to use birth control. Those with more than two transplants, significant medical conditions like heart failure or uncontrolled diabetes, active infections including hepatitis B/C or HIV, bleeding disorders, CNS involvement by MDS, or allergies to similar drugs cannot join.Check my eligibility
What is being tested?
The trial tests how well magrolimab combined with azacitidine works after an allogeneic hematopoietic cell transplantation (donor stem cell transplant). Magrolimab is an antibody targeting CD47 on cancer cells to help the immune system destroy them. Azacitidine is a chemotherapy drug that stops cancer growth in various ways. The study aims to see if this combination can better eliminate cancer cells post-transplant.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's increased activity against cancer cells which may affect normal tissues as well. Chemotherapy with azacitidine might cause nausea, low blood counts leading to infection risk increase or bleeding problems; fatigue; and injection site reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities
Maximum tolerated dose (MTD) and recommended phase 2 dose (RPD) of magrolimab
Secondary outcome measures
Completion of planned therapy
Cumulative incidence of acute graft versus host disease (aGvHD) of grades 2-4 and 3-4
Cumulative incidence of chronic graft versus host disease (cGvHD)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (magrolimab, azacitidine)Experimental Treatment9 Interventions
Patients undergo allo HCT per standard of care. Patients then receive magrolimab IV and azacitidine IV on study. Patients undergo ECHO or MUGA during screening and blood sample collection and bone marrow biopsy and aspirate throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Magrolimab
2021
Completed Phase 2
~170
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Azacitidine
2012
Completed Phase 3
~1440
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,616 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,397 Total Patients Enrolled
Monzr M Al MalkiPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
290 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Patients scheduled for their initial or subsequent Hematopoietic Cell Transplantation with a diminished-intensity conditioning plan (in accordance with institutional regulations) and any Graft-versus-Host Disease prophylaxis regimen are eligible.Your creatinine clearance is determined by a 24-hour urine test or the Cockcroft-Gault formula and must be at least 60 mL/min within 45 days prior to transplant, unless otherwise specified.Your Aspartate transaminase (AST) level must be equal to or lower than 1.5 times the Upper Limit of Normal, measured within 45 days prior to transplantation unless otherwise specified.You are between 18 and 75 years old.Females and males of childbearing potential must agree to utilize a reliable contraception technique or abstain from heterosexual activity during the duration of the study, extending at least 6 months after their final dose of protocol therapy.You are either not surgically sterilized or have been menstruating for less than a year (for women only).There is a chance that your nervous system is affected by MDS.The patient or legally authorized representative must provide documented consent within 30 days of the start date for HCT.You agree to the utilization of archival tissue from diagnostic tumor biopsies, and exceptions may be granted with the PI's permission.You have had an allergic reaction to drugs similar to azacitidine or magrolimab.You have a medical condition that, according to the doctor, makes it unsafe for you to participate in the study.Pre-HCT exposure to anti-CD47 of HMA is permissible if no deterioration in condition has been reported.Your absolute neutrophil count has been at least 1.5 for the last two weeks, without relying on granulocyte-colony stimulating factor (GCSF)Allogeneic transplants of any donor type or graft source are included.Alanine transaminase must be 1.5 times or lower than the upper limit of normal, as determined within 45 days prior to transplantation, unless otherwise indicated.You have an Eastern Cooperative Oncology Group score of 2 or less.You are scheduled for allogeneic hematopoietic cell transplantation (HCT) due to acute myeloid leukemia (AML) with high-risk cytogenetics as defined by the European Leukemia Net or myelodysplastic syndrome (MDS) with an International Prognostic Scoring System of intermediate 2 and poor risk cytogenetics/molecular markers, positive minimal residual disease, or active disease but less than 10% blasts at HCT.Your platelet count must be 50,000 or higher within 45 days prior to transplantationYour total bilirubin level is at or below 1.5 times the upper limit of normal (ULN) unless you have Gilbert's disease, and should be tested within 45 days prior to transplantation, unless otherwise stated.Your left ventricular ejection fraction must be at least 45%, as measured within the preceding 45 days (unless otherwise specified).If able to perform pulmonary function tests, the FEV1, FVC and DLCO must be at least 50% of predicted (corrected for hemoglobin)Women of childbearing potential must demonstrate a negative result on either a urine or serum pregnancy test to qualify; if the urine test is positive or inconclusive, then a serum pregnancy test must be conducted within 45 days prior to transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (magrolimab, azacitidine)
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.
Is there an opportunity for me to get involved in this medical research?
"This clinical trial is seeking 44 individuals, aged 18-75, who have been diagnosed with acute myeloid leukemia."
Answered by AI
Are elderly individuals eligible for enrollment in this experiment?
"The age requirements for this study are 18 years and older, with no upper limit exceeding 75."
Answered by AI
Has the FDA sanctioned magrolimab and azacitidine as viable treatment options?
"Since this is an experimental stage 1 trial, the safety of magrolimab and azacitidine has been judged to be low-level at a rating of 1. The data available on these treatments' effectiveness and security are scanty."
Answered by AI
Is there presently an opportunity to join this research endeavor?
"Per the clinicaltrials.gov website, no new participants are being sought at this time for this medical study which was posted in September of 2023 and last amended on April 10th of same year. Although closed to recruitment, there exist 779 other trials actively enrolling patients right now."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger