Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

November 28, 2024 updated by: Gilead Sciences

A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies

The primary objectives of this study are:

  • To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS
  • To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS
  • To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LE
        • Oxford Centre for Respiratory Medicine Churchill Hospital, Oxford University Hospitals NHS Trust
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92093
        • University of California San Diego (UCSD)
      • Los Angeles, California, United States, 90095
        • UCLA Clinical and Translational Research Center (CTRC)
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center - UC Irvine Medical Center
      • Sacramento, California, United States, 95817
        • University of California Davis Comprehensive Cancer Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University Of Miami - Miller School Of Medicine, Sylvester Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute/ Boston Children's Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Mid America Division, Inc.
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Weill Cornell Medical College - New York-Presbyterian Hospital
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennesssee Oncology - Centennial Clinic Location
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Simmons Cancer Center
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of WI Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Meets the criteria below for the appropriate cohort:

    • Relapsed/Refractory Cohorts: Pathologically confirmed relapsed or refractory (primary refractory and/or relapsed refractory) acute myeloid leukemia (AML) or confirmed intermediate, high, or very high risk myelodysplastic syndromes (MDS) that is relapsed, refractory or intolerant to conventional therapy.
    • Treatment-naive/Unfit Cohorts: Previously untreated individuals with histological confirmation of AML who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen; or previously untreated individuals with intermediate, high, or very high risk MDS. Prior and concurrent therapy with hydroxyurea, oral etoposide, erythroid and/or myeloid growth factors is allowed.
    • Rollover Cohort: Individuals on active magrolimab therapy on the Phase 1 AML (SCI-CD47-002; NCT02678338) trial who are deriving clinical benefit by Investigator assessment.
    • RBC transfusion dependent low risk MDS cohort: Transfusion-dependent MDS individuals who are very low or low risk by Revised International Prognostic Scoring System (IPSS-R) with previous treatment with an erythroid stimulating agent or lenalidomide.
  • White blood cell (WBC) count ≤ 20 x 10^3/mcL
  • Adequate performance status and hematological, liver, and kidney function.

Key Exclusion Criteria:

  • Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents (with exception of magrolimab for individuals in the Rollover cohort).
  • Treatment-naive/Unfit Cohorts Only: Any prior anti-leukemic therapy (excluding hydroxyurea or oral etoposide), prior treatment with hypomethylating agents and/or low dose cytarabine.
  • Acute promyelocytic leukemia.
  • Known inherited or acquired bleeding disorders.
  • Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant-related immunosuppression.
  • Clinical suspicion of active central nervous system (CNS) involvement by leukemia.
  • Known active or chronic hepatitis B or C infection or HIV.
  • Pregnancy or active breastfeeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TN MDS Cohort Higher Risk QW 30 mg/kg
Participants who are treatment-naive (TN) with higher risk myelodysplastic syndrome (MDS) 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 Days 11, 15, 22, and then weekly (QW) starting Cycle 2 up to end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: TN MDS Cohort Higher Risk Q2W 30 mg/kg
Participants who are TN with higher risk MDS 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 Days 11, 15, 22, and then weekly starting Cycle 2 and given every 2 weeks (Q2W) from Cycle 3 up to end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: TN/U AML Cohort: Magrolimab + Azacitidine
Participants who are treatment-naive or unfit (TN/U) with acute myeloid leukemia (AML) 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 Days 11, 15, 22, and then QW starting Cycle 2 and then given QW and Q2W from Cycle 3 up to end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: R/R AML Cohort: Magrolimab + Azacitidine
Participants with relapsed/refractory (r/r) AML will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg QW and Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: R/R AML Cohort: Magrolimab
Participants with r/r AML will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, Day 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Day 11 and Day 15, 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, and 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Experimental: Rollover AML Cohort: Magrolimab
Participants may receive the same dose level and schedule (30 mg/kg) (i.e., twice weekly) of magrolimab monotherapy in each cycle (each cycle was of 28 days) as previously received on the Phase 1 AML study (SCI-CD47-002), or may transition to once-weekly dosing in this study at the discretion of the Investigator in each 28-day cycle and with Sponsor approval. Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Experimental: R/R MDS Cohort: Magrolimab + Azacitidine
Participants with r/r MDS will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: R/R MDS Cohort: Magrolimab to Magrolimab + Azacitidine

Participants with r/r MDS will receive magrolimab 1 mg/kg for Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8, 30 mg/kg on Cycle 1 Days 11, 15 and 22 through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Participants will receive azacitidine 75 mg/m^2 on Days 1 to 7 of each cycle (each cycle was of 28 days). Maximum treatment duration was up to 4 years.

Participants with r/r MDS who do not have an objective response with magrolimab at the first protocol response assessment can have azacitidine added to magrolimab for subsequent cycles.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: R/R MDS Cohort: Magrolimab
Participants with r/r MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11, 15, 22, through end of Cycle 2 and then 30 mg/kg QW in Cycle 2 and then 30 mg/kg Q2W starting Cycle 3 and thereafter (each cycle was of 28 days). Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Experimental: Low Risk MDS Cohort: Magrolimab + Azacitidine
Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: Low Risk MDS Cohort: Magrolimab to Magrolimab + Azacitidine

Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Participants will receive azacitidine 75 mg/m^2 on Days 1 to 5 of each cycle. For participants who could not tolerate 60 mg/kg dose, the dose of magrolimab was reduced to 45 mg/kg. Maximum treatment duration was up to 4 years.

Participants with r/r MDS who do not have an objective response with magrolimab at the first protocol response assessment can have azacitidine added to magrolimab for subsequent cycles.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4
Drug: Azacitidine
Administered according to region-specific drug labeling either subcutaneously or intravenously
Other Names:
  • VIDAZA
Experimental: Low Risk MDS Cohort: Magrolimab
Participants with low risk MDS will receive 1 mg/kg magrolimab on Cycle 1 Week 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15 and 22; 60 mg/kg on Day 1 of Cycle 2 and subsequent cycles (each cycle was of 28 days) (each cycle was of 28 days) up to the end of the study. Maximum treatment duration was up to 4 years.
Drug: Magrolimab
Administered intravenously
Other Names:
  • Hu5F9-G4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 4 years
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and before the first date of new anti-cancer therapy including stem-cell transplant (SCT) and/or any AEs leading to premature discontinuation of study drug.
Up to 4 years
Complete Remission (CR) Rate For Participants With AML
Time Frame: Up to 5 years
The CR rate is the percentage of participants who achieved CR without minimal residual disease (CRMRD-), and CR as per European Leukemia Net (ELN) AML recommendations. CRMRD- per ELN was defined as neutrophils ≥1.0 × 10^9/L; platelets ≥100 × 10^9/L and <5% bone marrow blasts. If studied pretreatment, CR with negativity for a genetic marker by real-time quantitative polymerase chain reaction (RT-qPCR) or similar modality or CR with negativity by multi-color flow cytometry. CR per ELN criteria is defined as neutrophils ≥1.0 × 10^9/L; platelets ≥100 × 10^9/L and <5% bone marrow blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown.
Up to 5 years
CR Rate for Participants With MDS
Time Frame: Up to 5 years
The CR rate was the percentage of MDS participants who achieved CR per International Working Group (IWG) 2006 criteria. CR per IWG criteria is defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood should have: Hemoglobin (Hgb) ≥11 g/dL, platelets ≥100 × 10^9/L, neutrophils ≥1.0 × 10^9/L and blasts 0%.
Up to 5 years
Percentage of Participants With Red Blood Cell (RBC) Transfusion Independence for Participants With Low-Risk MDS
Time Frame: Up to 8 weeks
RBC transfusion independence was defined by the lack of RBC transfusions for at least an 8 week consecutive period at any time after starting therapy.
Up to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Concentration for Magrolimab in TN/U AML and TN MDS Participants
Time Frame: Predose and/or after 1 hour of infusion (duration 3 hours (± 30 minutes) for 1mg/kg; 2 hours for 15 mg/kg, 30 mg/kg and 60 mg/kg) in Cycles (each cycle of 28 days) 1 to 7, 9, 11, 13, 15, on Days 1, 2, 3, 4, 8, 11, 15, 16, 17, 18, 22, EOT, Safety Follow-up
Predose and/or after 1 hour of infusion (duration 3 hours (± 30 minutes) for 1mg/kg; 2 hours for 15 mg/kg, 30 mg/kg and 60 mg/kg) in Cycles (each cycle of 28 days) 1 to 7, 9, 11, 13, 15, on Days 1, 2, 3, 4, 8, 11, 15, 16, 17, 18, 22, EOT, Safety Follow-up
Percentage of Participants Who Developed Anti-Magrolimab Antibodies
Time Frame: Up to 5 years
As per the pre-specified analysis, this outcome measure was analyzed based on different dosing regimens and timepoints when magrolimab was given alone and in combination with the azacitidine. Therefore, the data is reported for magrolimab as monotherapy and magrolimab plus azacitidine. Also, the arms are based on the frequency of magrolimab administered: QW, Q2W, QW to Q2W, Q4W, BIW and BIW to QW as applicable in different cohorts.
Up to 5 years
Duration of Complete Remission (DCR) in Participants With AML and MDS
Time Frame: Up to 5 years

For AML participants: The DCR was defined as the time measurement criteria were first met for CR (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR) until the first date that recurrent disease or death with evidence of no disease recurrence was objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR was defined as complete disappearance of chromosomal abnormality without appearance of new ones. mCR was defined as morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast.

For MDS participants: The DCR was defined as the time measurement criteria were first met for CR until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented.

Kaplan-Meier (KM) estimates were used in the outcome measure analysis.
Up to 5 years
Percentage of MDS Participants With Objective Response Rate (ORR) as Defined by IWG 2006 MDS Response Criteria
Time Frame: Up to 5 years

ORR was the percentage of participants who achieved CR, partial remission (PR), marrow CR or hematological improvement (HI) prior to initiation of a new anticancer therapy including SCT per IWG 2006 criteria per investigator's evaluation. CR was defined in outcome measure 2. PR was defined as all CR criteria if abnormal before treatment except the bone marrow blasts decreased by 50% over pretreatment but still > 5% and cellularity and morphology not relevant. Marrow CR is defined as bone marrow ≤5% myeloblasts and decrease by ≥50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR. Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks.

Percentages were rounded off.
Up to 5 years
Percentage of AML Participants With Objective Response Rate (ORR)
Time Frame: Up to 5 years
ORR is the percentage of participants who achieve CR, CR with incomplete hematologic (count) recovery (CRi), CR with partial hematologic (count) recovery (CRh), Partial Response (PR), Morphologic Leukemia-Free State (MLFS) prior to initiation of a new anti-cancer therapy including SCT per European Leukemia Net (ELN) AML 2017 recommendations per investigator's evaluation. CR was defined in outcome measure 2. CRi was defined as neutrophils ≥ 1.0 × 10^9/L or platelets ≥ 100 × 10^9/L bone marrow blasts < 5%. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; MRD positive or unknown. CRh was defined in outcome measure 10. PR was defined in outcome measure 8. MLFS was defined as bone marrow blasts < 5%. Absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; marrow should not merely be "aplastic"; at least 200 cells should be enumerated or cellularity should be at least 10%.
Up to 5 years
Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh) for AML Participants
Time Frame: Up to 5 years
CRh was defined as CR with partial platelet and absolute neutrophil count recovery while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT).
Up to 5 years
Duration of Response (DOR) for Participants With AML
Time Frame: Up to 5 years

The DOR was defined as time measurement criteria were met for complete remission (CR) (including morphologic CR, CRMRD-, cytogenetic complete remission (cCR), and molecular complete remission (mCR), incomplete blood count recovery (CRi), partial hematologic recovery (CRh), partial remission (PR), marrow CR, or morphologic leukemia-free state (MLFS), whichever was first recorded, until the first date that recurrent or progressive disease, or death with evidence of no disease magrolimab progression is objectively documented. CR and CRMRD- were defined in outcome measure 2. cCR and mCR were defined in outcome measure 7. Marrow CR and PR were defined in outcome measure 8. CRi and MLFS were defined in outcome measure 9. CRh was defined in outcome measure 10.

KM estimates were used in the outcome measure analysis.
Up to 5 years
Duration of Response for Participants With MDS
Time Frame: Up to 5 years

The DOR was measured from the time measurement criteria were first met for objective response as assessed by IWG MDS criteria until the first date that recurrent disease or death with evidence of no disease recurrence is objectively documented.

KM estimates were used in the outcome measure analysis.
Up to 5 years
Overall Survival (OS) for Participants With AML or MDS
Time Frame: Up to 5 years

The length of overall survival will be measured from the date of study treatment initiation until the date of death from any cause.

KM estimates were used in the outcome measure analysis.
Up to 5 years
Progression Free Survival (PFS) for Participants With AML or MDS
Time Frame: Up to 5 years

The length of PFS is defined as the time from the date of study treatment initiation until the date of documented disease progression (PD) or death from any cause, whichever occurs first.

PD for MDS: <5% blasts: if blasts increase ≥50% to >5%; 5%-10% blasts: if blasts increase ≥50% to >10%; 10%-20% blasts: if blasts increase ≥50% to >20%; 20%-30% blasts: if blasts increase ≥50% to >30%. Participants with at least 50% decrement from maximum remission/response in granulocytes / platelets or reduction in Hgb by ≥ 2 g/dL or transfusion dependence. PD for AML was defined as any evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood: > 50% increase in marrow blasts over baseline (a minimum 15% point increase is required in cases with < 30% blasts at baseline; or persistent marrow blast percentage of >70% over at least 3 months; without at least a 100% improvement in absolute neutrophil count.
Up to 5 years
Relapse Free Survival (RFS) for Participants With AML or MDS
Time Frame: Up to 5 years
The length of RFS is defined from the first date of attaining a CR (including morphologic CR, CRMRD-, cCR, and mCR) until the date of AML relapse or death from any cause, whichever occurs first.
Up to 5 years
Event Free Survival (EFS) for Participants With AML or MDS
Time Frame: Up to 5 years

For AML, EFS was defined as the time from the date of study treatment initiation until the date of documented disease progression, death from any cause, or treatment failure (defined as failure to achieve CR/CRi/CRh by Cycle 5 Day 1), whichever occurred first. CR/CRi/CRh were defined in outcome measures 2, 9 and 10 respectively.

For MDS, EFS was defined as the time from the date of study treatment initiation to transformation to AML or death from any cause, whichever occurred first. Participants who were not observed to have one of these events during the study were censored at their last response assessment date with evidence of no transformation to AML.

KM estimates were used in the outcome measure analysis.
Up to 5 years
Change From Baseline in Hemoglobin on Therapy
Time Frame: Baseline and Day 1
Baseline and Day 1
12-week RBC Transfusion Independence Rates
Time Frame: Up to 12 Weeks
Up to 12 Weeks
Minimal Residual Disease (MRD) Negative Response Rate
Time Frame: Up to 5 years
The MRD-negative response rate was defined as the percentage of participants who reach MRD-negative disease status prior to initiation of other new anti-cancer therapy including SCT and achieve a morphologic CR or marrow CR for MDS participants and achieve CR/CRi/CRh/MLFS for AML participants. MRD-negative disease status will be assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. CR/CRi/MLFS/CRh were defined in outcome measures 2, 9, 10 respectively. Marrow CR was defined in outcome measure 8.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5F9005
  • 2017-000678-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematological Malignancies

Clinical Trials on Magrolimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings