Trial · NCT05079230
Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
NCT05079230, Phase 3, Terminated, Gilead Sciences; results first posted 2025-04-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia. Trials, record NCT05079230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05079230
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
- NCT number
- NCT05079230
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 378 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Magrolimab, Venetoclax, Azacitidine, Placebo
- First posted
- 2021-10-15
- Last updated
- 2025-04-04
- Other registries' IDs
- eudract:2021-003434-36
- Results first posted
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to 1.6 years | OS was measured from the date of randomization to the date of death from any cause. Participants were censored at last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis. |
| Secondary | Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh) | Up to 1.6 years | The CR + CRh rate was defined as the percentage of participants who achieved a CR (including CR without minimal residual disease (CRMRD-) and CR with positive or unknown MRD (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). CRMRD- and CRMRD+/unk: neutrophils \>1.0 ×10\^9/L, platelets \>100 ×10\^9/L, \<5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry \<0.1% sensitivity for CRMRD-) within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. |
| Secondary | Rate of Complete Remission (CR) | Up to 1.6 years | CR was defined as the percentage of the participants who achieved CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT) within the response assessment window of 1.6 years. Definitions for CRMRD- and CRMRD+/unk were mentioned in outcome measure #2. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days. |
| Secondary | Event-Free Survival (EFS) | Up to 1.6 years | EFS was defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause within the response window. KM estimates were used in outcome measure analysis. CR is defined in outcome measure 2. |
| Secondary | Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) | Up to 1.6 years | The duration of CR + CRh was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cut off date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR and CRh are defined in Outcome Measure #2. Each cycle was of 28 days. |
| Secondary | Duration of Complete Remission (DCR) in Participants Who Achieved Complete Remission (CR) | Up to 1.6 years | The DCR was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cutoff date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. KM estimates were used in outcome measure analysis. CRMRD- and CRMRD+/unk are defined in outcome measure #2. Each cycle was of 28 days. |
| Secondary | Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-) | Up to 1.6 years | The CR/CRhMRD- rate was the percentage of participants who achieved a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 1.6 years. Each cycle was of 28 days. KM estimates were used for outcome measure analysis. CRhMRD- : neutrophils \> 0.5 x 10\^9/L; platelets \> 50 x 10\^9/L; bone marrow blasts \< 5%; MRD negative (determined using multiparameter flow cytometry with a sensitivity of \< 0.1%). Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Percentages were rounded off. |
| Secondary | Rate of CR Without Minimal Residual Disease (CRMRD-) | Up to 1.6 years | The CRMRD- rate was the percentage of participants who achieved a CRMRD- within 6 cycles of treatment SCT within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. CRMRD is defined in outcome measure #2. Each cycle was of 28 days. Percentages were rounded off |
| Secondary | Red Blood Cell (RBC) Transfusion Independence Conversion Rate | Up to 1.6 years | The RBC transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were RBC transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. |
| Secondary | Platelet Transfusion Independence Conversion Rate | Up to 1.6 years | The platelet transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no platelet transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were platelet transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to 1.6 years | Participants in the Intent-to-Treat Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh) | Up to 1.6 years | Participants in the Intent-to-Treat analysis set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Rate of Complete Remission (CR) | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Event-Free Survival (EFS) | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set were analyzed. | months | MEDIAN |
| SECONDARY | Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set who achieved CR + CRh within 6 cycles were analyzed. Each cycle was of 28 days. | months | MEDIAN |
| SECONDARY | Duration of Complete Remission (DCR) in Participants Who Achieved Complete Remission (CR) | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set who achieved CR within 6 cycle in all participants were analyzed. Each cycle was of 28 days. | months | MEDIAN |
| SECONDARY | Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-) | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Rate of CR Without Minimal Residual Disease (CRMRD-) | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Red Blood Cell (RBC) Transfusion Independence Conversion Rate | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set with RBC transfusion dependence at Baseline were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Platelet Transfusion Independence Conversion Rate | Up to 1.6 years | Participants in the Intent-To-Treat Analysis Set with Platelet transfusion dependence at Baseline were analyzed. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Magrolimab + Venetoclax + Azacitidine | 10.7 | 95% Confidence Interval 8.7 to 14.9 | months | |
| Overall Survival (OS) | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 14.1 | 95% Confidence Interval 9.7 to NA | months | |
| Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh) | Magrolimab + Venetoclax + Azacitidine | 47.6 | 95% Confidence Interval 40.3 to 55.0 | percentage of participants | |
| Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh) | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 53.4 | 95% Confidence Interval 46.1 to 60.7 | percentage of participants | |
| Rate of Complete Remission (CR) | Magrolimab + Venetoclax + Azacitidine | 41.3 | 95% Confidence Interval 34.2 to 48.6 | percentage of participants | |
| Rate of Complete Remission (CR) | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 46.0 | 95% Confidence Interval 38.8 to 53.4 | percentage of participants | |
| Event-Free Survival (EFS) | Magrolimab + Venetoclax + Azacitidine | 0.0 | 95% Confidence Interval 0.0 to 5.4 | months | |
| Event-Free Survival (EFS) | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 1.7 | 95% Confidence Interval 0.0 to 4.5 | months | |
| Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) | Magrolimab + Venetoclax + Azacitidine | 9.4 | 95% Confidence Interval 5.9 to NA | months | |
| Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh) | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 9.2 | 95% Confidence Interval 5.8 to NA | months |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 + Venetoclax + Azacitidine | 189 | |
| Overall Study | STARTED | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 189 | |
| Overall Study | COMPLETED | Magrolimab + Venetoclax + Azacitidine | 0 | |
| Overall Study | COMPLETED | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 0 | |
| Overall Study | NOT COMPLETED | Magrolimab + Venetoclax + Azacitidine | 189 | |
| Overall Study | NOT COMPLETED | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 189 |
Source ClinicalTrials.gov
Adverse events542
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 + Venetoclax + Azacitidine | 92 | 189 | |
| other | Anaemia | Blood and lymphatic system disorders | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 63 | 184 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Magrolimab + Venetoclax + Azacitidine | 38 | 189 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 31 | 184 | |
| other | Neutropenia | Blood and lymphatic system disorders | Magrolimab + Venetoclax + Azacitidine | 67 | 189 | |
| other | Neutropenia | Blood and lymphatic system disorders | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 76 | 184 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Magrolimab + Venetoclax + Azacitidine | 39 | 189 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 47 | 184 | |
| other | Atrial fibrillation | Cardiac disorders | Magrolimab + Venetoclax + Azacitidine | 18 | 189 | |
| other | Atrial fibrillation | Cardiac disorders | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 9 | 184 |
1 to 10 of 542Source ClinicalTrials.gov
See all 542 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Magrolimab + Venetoclax + Azacitidine | 84 | 189 |
| Total, all-cause mortality | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 70 | 189 |
| Total, other adverse events | Magrolimab + Venetoclax + Azacitidine | 180 | 189 |
| Total, other adverse events | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 179 | 184 |
| Total, serious adverse events | Magrolimab + Venetoclax + Azacitidine | 138 | 189 |
| Total, serious adverse events | Magrolimab Matching Placebo + Venetoclax + Azacitidine | 134 | 184 |
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 + Venetoclax + Azacitidine vs Magrolimab Matching Placebo + Venetoclax + Azacitidine: deaths from any cause | Trial comparisons |
| Magrolimab + Venetoclax + Azacitidine vs Magrolimab Matching Placebo + Venetoclax + 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/NCT05079230
GET https://conductscience.org/api/trials/v1/NCT05079230/results?page=2