Trial · NCT04313881
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
NCT04313881, Phase 3, Terminated, Gilead Sciences; results first posted 2024-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS). Trials, record NCT04313881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04313881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
- NCT number
- NCT04313881
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 539 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Magrolimab, Azacitidine, Placebo
- First posted
- 2020-03-18
- Last updated
- 2024-06-27
- Other registries' IDs
- eudract:2020-004287-26
- Results first posted
- 2024-03-21
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Remission (CR) | From randomization up to 31.01 months | The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off. |
| Primary | Overall Survival (OS) | From randomization up to 32.62 months | OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis. |
| Secondary | Duration of CR (DOCR) | From randomization up to 31.01 months | DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. PD is defined as: \<5% blasts: ≥50 increase in blasts to \>5% blasts,5%-10% blasts: ≥50% increase in blasts to \>10% blasts, 10%-20% blasts: ≥50% increase in blasts to \>20% blasts,20%-30% blasts: ≥50% increase in blasts to \>30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by ≥2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis. |
| Secondary | Objective Response Rate (ORR) | From randomization up to 31.01 months | ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1. PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by ≥ 50% over pretreatment but still \> 5% 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. |
| Secondary | Duration of Response (DOR) | From randomization up to 31.01 months | DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis. |
| Secondary | Red Blood Cell (RBC) Transfusion Independence Rate | From randomization up to 31.01 months | RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off. |
| Secondary | Event Free Survival (EFS) | From randomization up to 31.01 months | EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first. Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis |
| Secondary | Percentage of Participants With CR in Participants With TP53 Mutation | From randomization up to 31.01 months | CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off. |
| Secondary | Minimal Residual Disease (MRD)-Negative Response Rate | From randomization up to 31.01 months | The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory. Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively. Percentages were rounded off. |
| Secondary | Time to Transformation to AML | From randomization up to 31.01 months | Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. Transformation assessments post SCT were included in the analysis.KM estimates were used for analysis. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Remission (CR) | From randomization up to 31.01 months | Participants from intent-to-treat analysis set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (OS) | From randomization up to 32.62 months | Participants from intent-to-treat analysis set were analyzed. | months | MEDIAN |
| SECONDARY | Duration of CR (DOCR) | From randomization up to 31.01 months | Participants from intent-to-treat analysis set who achieved CR were analyzed. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From randomization up to 31.01 months | Participants from intent-to-treat analysis set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From randomization up to 31.01 months | Participants from intent-to-treat analysis set with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Red Blood Cell (RBC) Transfusion Independence Rate | From randomization up to 31.01 months | Participants from intent-to-treat analysis set who were RBC transfusion-dependent at baseline were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event Free Survival (EFS) | From randomization up to 31.01 months | Participants from intent-to-treat analysis set were analyzed. | months | MEDIAN |
| SECONDARY | Percentage of Participants With CR in Participants With TP53 Mutation | From randomization up to 31.01 months | Participants from intent-to-treat analysis set with TP53 mutation were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD)-Negative Response Rate | From randomization up to 31.01 months | Participants from intent-to-treat analysis set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Time to Transformation to AML | From randomization up to 31.01 months | Participants from intent-to-treat analysis set were analyzed. | months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Remission (CR) | Magrolimab + Azacitidine | 21.3 | 95% Confidence Interval 16.5 to 26.7 | percentage of participants | |
| Percentage of Participants With Complete Remission (CR) | Placebo + Azacitidine | 23.6 | 95% Confidence Interval 18.7 to 29.1 | percentage of participants | |
| Overall Survival (OS) | Magrolimab + Azacitidine | 15.9 | 95% Confidence Interval 13.3 to 19.5 | months | |
| Overall Survival (OS) | Placebo + Azacitidine | 18.6 | 95% Confidence Interval 14.9 to 26.2 | months | |
| Duration of CR (DOCR) | Magrolimab + Azacitidine | 10.9 | 95% Confidence Interval 8.9 to 16.7 | months | |
| Duration of CR (DOCR) | Placebo + Azacitidine | 11.1 | 95% Confidence Interval 8.1 to NA | months | |
| Objective Response Rate (ORR) | Magrolimab + Azacitidine | 53.7 | 95% Confidence Interval 47.6 to 59.8 | percentage of participants | |
| Objective Response Rate (ORR) | Placebo + Azacitidine | 58.7 | 95% Confidence Interval 52.6 to 64.6 | percentage of participants | |
| Duration of Response (DOR) | Magrolimab + Azacitidine | 10.1 | 95% Confidence Interval 8.1 to 12.5 | months | |
| Duration of Response (DOR) | Placebo + Azacitidine | 10.2 | 95% Confidence Interval 7.6 to 12.9 | months |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Magrolimab + Azacitidine | 268 | |
| Overall Study | STARTED | Placebo + Azacitidine | 271 | |
| Overall Study | COMPLETED | Magrolimab + Azacitidine | 0 | |
| Overall Study | COMPLETED | Placebo + Azacitidine | 0 | |
| Overall Study | NOT COMPLETED | Magrolimab + Azacitidine | 268 | |
| Overall Study | NOT COMPLETED | Placebo + Azacitidine | 271 |
Source ClinicalTrials.gov
Adverse events678
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Magrolimab + Azacitidine | 124 | 263 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Azacitidine | 75 | 264 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Magrolimab + Azacitidine | 14 | 263 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo + Azacitidine | 14 | 264 | |
| other | Neutropenia | Blood and lymphatic system disorders | Magrolimab + Azacitidine | 63 | 263 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Azacitidine | 60 | 264 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Magrolimab + Azacitidine | 54 | 263 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Azacitidine | 46 | 264 | |
| other | Atrial fibrillation | Cardiac disorders | Magrolimab + Azacitidine | 17 | 263 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo + Azacitidine | 9 | 264 |
1 to 10 of 678Source ClinicalTrials.gov
See all 678 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Magrolimab + Azacitidine | 145 | 268 |
| Total, all-cause mortality | Placebo + Azacitidine | 132 | 271 |
| Total, other adverse events | Magrolimab + Azacitidine | 246 | 263 |
| Total, other adverse events | Placebo + Azacitidine | 256 | 264 |
| Total, serious adverse events | Magrolimab + Azacitidine | 189 | 263 |
| Total, serious adverse events | Placebo + Azacitidine | 136 | 264 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Magrolimab + Azacitidine vs Placebo + Azacitidine: deaths from any cause | Trial comparisons |
| Magrolimab + Azacitidine vs Placebo + Azacitidine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04313881
GET https://conductscience.org/api/trials/v1/NCT04313881/results?page=2