Your session is about to expire
← Back to Search
Anti-metabolites
Magrolimab for Blood Cancers
Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing the safety and efficacy of magrolimab, a new drug, in people with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. The primary objectives are to confirm the safety and tolerability of magrolimab and to evaluate the efficacy of magrolimab in achieving complete remission.
Eligible Conditions
- Blood Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Complete Remission (CR) Rate For Participants With AML
Complete Remission Rate for Participants with MDS
Duration of Complete Remission (DCR) in Participants with AML and MDS
+2 moreSecondary outcome measures
12-week RBC Transfusion Independence Rates
Complete Remission with Partial Hematologic Recovery (CRh)
Duration of Response (DOR) for Participants with AML
+13 moreSide effects data
From 2020 Phase 1 & 2 trial • 78 Patients • NCT0295378267%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Myalgia
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypokalaemia
11%
Tumour pain
11%
Hypertension
11%
Dyspnoea
11%
Dyspepsia
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only
Trial Design
8Treatment groups
Experimental Treatment
Group I: Treatment-naive Unfit (TNU) Dose Expansion CohortExperimental Treatment2 Interventions
Participants will receive 1 mg/kg magrolimab twice weekly for Cycle 1; 15 mg/kg weekly for Cycle 1 Day 8; 30 mg/kg weekly through end of cycle 2; and then 30 mg/kg every 2 weeks starting Cycle 3 up to end of the study + azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle.
Group II: Treatment-naive Unfit (TNU) Dose Evaluation CohortExperimental Treatment2 Interventions
Participants will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Day 11, 15, 22, and then weekly starting Cycle 2 up to end of the study + azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle.
Group III: RolloverExperimental Treatment1 Intervention
Participants on a previous AML Phase 1 trial (SCI-CD47-002; NCT02678338) with clinical benefit on magrolimab treatment will receive the same dose level (0.1 mg/kg up to 30.0mg/kg based on the cohort to which the participant was assigned) twice weekly or may transition to once weekly dosing at the discretion of the Investigator and approval from Gilead.
Group IV: RBC transfusion-dependent low-risk MDS, Safety Run-in PhaseExperimental Treatment2 Interventions
Participants will receive 1 mg/kg magrolimab on Cycle 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15, and 22; and 60 mg/kg every 4 weeks starting on Cycle 2 Day 1 and thereafter up to end of the study. For participants who do not respond after Cycle 2, azacitidine 75 mg/m^2 may be added on subsequent cycles (ie starting at Cycle 3) on Days 1 to 5 of each cycle.
Group V: RBC transfusion-dependent low-risk MDS, Expansion PhaseExperimental Treatment2 Interventions
Participants will receive 1 mg/kg magrolimab on Cycle 1 Day 1; at 30 mg/kg on Cycle 1 Days 8, 15, and 22; and 60 mg/kg every 4 starting on Cycle 2 Day 1 and thereafter up to end of the study + azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle.
Group VI: R/R Safety CohortExperimental Treatment1 Intervention
Participants will receive 1 mg/kg magrolimab twice weekly for Cycle 1 Week 1 (Day 1 and 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11 and 15; and 30 mg/kg weekly thereafter starting Cycle 3 up to end of the study.
Group VII: R/R MDS Magrolimab Monotherapy CohortExperimental Treatment1 Intervention
Participants will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Day 11, 15, 22, weekly on Cycle 2, and then biweekly starting Cycle 3 up to end of the study.
Group VIII: R/R Expansion Cohort:Experimental Treatment2 Interventions
Participants will receive 1 mg/kg magrolimab twice weekly for Cycle 1 Week 1 (Day 1 and Day 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11 and 15; 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, then 30 mg/kg every 2 weeks starting Cycle 3 up to end of the study + azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magrolimab
2021
Completed Phase 2
~170
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,083 Previous Clinical Trials
843,101 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,435 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously received treatment with drugs that target CD47 or SIRPα, except for magrolimab in certain cases.There is a concern that the leukemia has spread to the brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: RBC transfusion-dependent low-risk MDS, Expansion Phase
- Group 2: Rollover
- Group 3: Treatment-naive Unfit (TNU) Dose Evaluation Cohort
- Group 4: R/R Expansion Cohort:
- Group 5: RBC transfusion-dependent low-risk MDS, Safety Run-in Phase
- Group 6: R/R MDS Magrolimab Monotherapy Cohort
- Group 7: Treatment-naive Unfit (TNU) Dose Expansion Cohort
- Group 8: R/R Safety Cohort
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.
Are there various locations participating in this research endeavor within the state?
"Currently 23 sites are involved in this study, located all around the United States including New york, Miami and Bronx. To reduce time spent travelling it is recommended that you select a location closest to your home if participating."
Answered by AI
For what purposes is Magrolimab prescribed?
"Magrolimab is largely used to combat malignant neoplasms, though it can also be utilized in the treatment of 20-30% blasts, neutropenia and/or thrombocytopenia, anemia."
Answered by AI
Has Magrolimab obtained regulatory authorization from the FDA?
"Due to the limited safety and efficacy data associated with Magrolimab, our team at Power gave it an assessment score of 1. This is a Phase 1 trial after all."
Answered by AI
To what extent is this research study being populated?
"This trial is no longer recruiting participants. It was first posted on September 8th, 2017 and its last update occurred October 10th of 2022. If you're interested in other clinical studies, 2527 different cancer trials are currently open to new enrollees while 185 Magrolimab focussed trials have available slots as well."
Answered by AI
Is there an ongoing recruitment effort for participants in this research?
"This clinical trial is no longer accepting patient applications. It was first made available on September 8th, 2017 with the last edit being October 10th 2022. For those looking for other studies involving cancer treatments there are currently 2527 trials enrolling and 185 specifically related to Magrolimab."
Answered by AI
Have any other exploratory tests been done with Magrolimab?
"Currently, there are 185 Magrolimab trials underway worldwide. 32 are in the final phase of testing and 5906 locations have enrolled patients in their experiments. The primary sites for these tests is Saint Louis, Missouri."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger