Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003833-13 | EudraCT Number |
Not provided
Not provided
Not provided
Sponsor decision to terminate the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab (Mag), in combination with anti-leukemia therapies in participants with acute myeloid leukemia (AML).
The anti-leukemia therapies are defined as follows:
This study consists of 3 safety run-in cohorts;
Participants will receive treatment at the assigned dose level for at least 4 cycles in the Safety Run-in cohorts, after which they may continue at the assigned dose level or switch to the RP2D upon agreement between the investigator and the sponsor. After completion of each safety run-in cohort and identification of the RP2D for that cohort, participants may be enrolled into the corresponding Phase 2 cohorts;
Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts.
Note: All cohorts are closed to screening and enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (1L Unfit AML): Magrolimab + Venetoclax + Azacitidine | Experimental | Participants with newly diagnosed untreated acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy will receive magrolimab 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose in every 28-day cycle along with azacitidine and venetoclax first in the Safety Run-in Cohort. Once the safety of recommended dose of magrolimab is confirmed, the participants in Phase 2 Cohort will be enrolled to receive the treatment. |
|
| Cohort 2 (R/R AML): Magrolimab + Mitoxantrone + Etoposide + Cytarabine | Experimental | Participants with relapsed/refractory (RR) AML after intensive induction chemotherapy will receive magrolimab 1 mg/ on Days 1, 4; 15 mg/kg, on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose along with mitoxantrone + etoposide + cytarabine (MEC) first in the Safety Run-in Cohort. Once the safety of recommended dose of magrolimab is confirmed, the participants in Phase 2 Cohort will be enrolled to receive the treatment. |
|
| Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Experimental | Participants with AML who achieved CR or CRi with MRD positivity following intensive induction chemotherapy will receive magrolimab 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose along with CC-486 as maintenance therapy first in the Safety Run-in Cohort. Once the safety of recommended dose of magrolimab is confirmed, the participants in Phase 2 Cohort will be enrolled to receive the treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magrolimab | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate (Cohorts 1 and 2) | CR rate was the percentage of participants who achieved CR (CR without minimal residual disease (CRMRD-) or complete remission with positive or unknown minimal residual disease (CRMRD+/unk)) as determined by the investigator based on prespecified criteria while on study prior to initiation of any new anti-cancer therapy. CRMRD- and CRMRD+/unk were 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. CRMRD- status as determined using multiparameter flow cytometry with a sensitivity of < 0.1%. Assessment of leukemia response in participants with acute myeloid leukemia (AML) were conducted based on the European Leukemia Net (ELN) recommendations for AML. Percentages were rounded-off. Clopper-Pearson method was used for outcome measure analysis. | Up to 2 years |
| Minimal Residual Disease Negative Complete Remission Rate (Cohort 3) | The minimal residual disease (MRD) negative CR rate was defined as the percentage of participants who maintain CR as determined by the investigator based on prespecified criteria and reach MRD negative disease status on 2 consecutive bone marrow assessments, as determined using multiparameter flow cytometry with a sensitivity of < 0.1% while on study prior to initiation of any new anti-AML therapy. Assessment of leukemia response in participants with AML were conducted based on the ELN recommendations for AML. CR was defined in outcome measure #1. | Up to 2 years |
| Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) (Safety Run-in Cohorts 1, 2 and 3) | DLTs were defined as any Grade 4 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity (that had worsened in severity from pretreatment baseline) during the 4-week DLT assessment period and was related to magrolimab or magrolimab combination. | Up to 28 days |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Cohorts 1, 2 and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was the percentage of participants who achieved CR (CRMRD- or CRMRD+/unk), CRi, CRh, PR, or MLFS as per investigator based on prespecified criteria before starting any new anti-AML therapy (including SCT). CRi and CRh were defined as neutrophils >0.5 x 10^9/L, platelets > 50 x 10^9/L (except residual neutropenia (<1.0 × 10^9/L) or thrombocytopenia (<100 × 109/L) for CRi) and bone marrow blasts <5%; Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. PR: Neutrophils >1.0 x 10^9/L, platelets >100 x 10^9/L, bone marrow blasts reduced to 5%-25%, and a ≥50% reduction from baseline. Blasts <5% with Auer rods may also be considered a PR. MLFS: Bone marrow blasts <5%, absence of circulating blasts or Auer rods, no extramedullary disease, marrow should not merely be "aplastic"; at least 200 cells or 10% cellularity, and no requirement for hematologic recovery. CR was defined in outcome measure #1. Percentages were rounded-off. |
Not provided
Key Inclusion Criteria:
All Individuals:
Safety Run-in Cohort 1 and Phase 2 Cohort 1 (Ineligible (1L) Unfit acute myeloid leukemia (AML) Magrolimab + Venetoclax + Azacitidine):
Newly diagnosed, previously untreated individuals with histological confirmation of AML by world health organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, comorbidity, or other factors. Individuals must be considered ineligible for induction therapy defined by the following:
≥ 75 years of age
≥ 18 to 74 years of age with at least 1 of the following comorbidities:
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
Individuals who have not received prior anti-leukemia therapy for AML (excluding hydroxyurea or oral etoposide), hypomethylating agent (HMA), low-dose cytarabine, and/or venetoclax. Individuals with prior myelodysplastic syndrome (MDS) cannot have received a prior HMA, venetoclax, or a chemotherapeutic agent. Other prior MDS therapies, including but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell (RBC) -direct therapies, are allowed
Individuals who have not received strong and/or moderate cytochrome P450 enzyme (CYP) 3A inducers (such as St. John's Wort) within 7 days prior to the initiation of study treatment
Individuals who have not consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment or are willing to discontinue consumption of these while receiving study drug
Individuals without malabsorption syndrome or other conditions that preclude enteral route of administration
Safety Run-in Cohort 2 and Phase 2 Cohort 2 (Relapsed/refractory (R/R) AML Magrolimab+Mitoxantrone + Etoposide + Cytarabine (MEC)):
Safety Run-in Cohort 3 and Phase 2 Cohort 3 (Post-chemo Maintenance Magrolimab+CC-486):
Key Exclusion Criteria:
Positive serum pregnancy test
Breastfeeding female
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
Individuals receiving any live virus vaccine within 4 weeks prior to initiation of study treatments
Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) -targeting agents
Current participation in another interventional clinical trial
Known inherited or acquired bleeding disorders
Clinical suspicion of or documented active CNS involvement with AML
Individuals who have acute promyelocytic leukemia
Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk: benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anti-cancer therapies and have had no evidence of active malignancy for over 1 year. Previous hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors are not criteria for exclusion
Known active or chronic hepatitis B or C infection or human immunodeficiency virus
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Mannis GN, Abboud C, Daver NG, Guru Murthy GS, Wang ES, Bradley TJ, et al. Tolerability and Efficacy of Magrolimab Plus Mitoxantrone, Etoposide, and Cytarabine (MEC) in Patients with Acute Myeloid Leukemia (AML) Refractory/Relapsed (R/R) After Induction Chemotherapy (IC). European Hematology Association (EHA) 13-16 June 2024. | ||
| 40364806 | Derived | Mannis GN, Abboud CN, Daver NG, Murthy GSG, Wang ES, Bradley TJ, Yaghmour G, Vachhani P, Balasubramanian SK, Chua CC, Fong CY, Asch AS, Dong M, Li S, Bagheri T, Doshi P, Vyas P, Malki MMA. Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Acute Myeloid Leukaemia. EJHaem. 2025 May 13;6(3):e70051. doi: 10.1002/jha2.70051. eCollection 2025 Jun. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were enrolled at study sites in the United States, the United Kingdom and Australia.
No participants were enrolled in Cohort 3, so, results are reported only for Cohorts 1 and 2.
Due to limited number of participants enrolled, and because all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and Phase 2 Cohorts were combined in outcome measures (OMs) except DLT OM, for which data was collected only in Safety Run-in Cohorts
77 participants were screened.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Safety Run-in Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine | Participants in Safety Run-in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Safety Run-in Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2023 | Nov 13, 2024 |
Not provided
After completion of Safety Run-in cohorts and identification of the RP2D for the specific cohorts, participants may be enrolled to the corresponding Phase 2 cohorts.
Not provided
Not provided
Not provided
Not provided
|
|
| Azacitidine | Drug | Administered either subcutaneously or IV, 75 mg/milligram per square (m^2) on Days 1 to 7 or Days 1 to 5, 8 and 9 during every cycle |
|
| Venetoclax | Drug | Administered orally at a dose of 100 mg on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle |
|
| Mitoxantrone | Drug | Administered intravenously, 8 mg/m^2 on Days 1-5 during Cycle 1 to Cycle 3 |
|
| Etoposide | Drug | Administered intravenously, 100 mg/m^2 on Days 1-5 during Cycle 1 to Cycle 3 |
|
| Cytarabine | Drug | Administered intravenously, 1000 mg/m^2 on Days 1-5 during Cycle 1 to Cycle 3 |
|
| CC-486 | Drug | Administered orally, 300 mg on Days 1-14 during each cycle |
|
|
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dosing date or the day before initiation of new anticancer therapy including SCT, whichever comes first. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Percentages were rounded-off. |
| First dose date up to 1.7 years plus 70 days |
| Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities (Cohorts 1, 2 and 3) | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 70 days or the day before initiation of any new anticancer therapy including SCT, whichever comes first. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment emergent. Percentages were rounded-off. | First dose date up to 1.7 years plus 70 days |
| Up to 2 years |
| Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR/CRh) (Cohorts 1 and 2) | CR/CRh rate was the percentage of participants who achieved CR (CRMRD- or CRMRD+/unk) or CRh as determined by the investigator based on prespecified criteria while on study prior to initiation of any new anti-AML therapy (including SCT). CR was defined in outcome measure 1. CRh was defined in outcome measure 6. Percentages were rounded-off. Clopper-Pearson exact method was used in outcome measure analysis. | Up to 2 years |
| Duration of Response (DOR) (Cohorts 1 and 2) | DOR was measured from the time assessment criteria that were met for CR (CRMRD- or CRMRD+/unk), CRi, CRh, PR, or MLFS, whichever was first recorded, until the first date of AML relapse, progressive disease, or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies.CR was defined in outcome measure #1. CRi, CRh, PR, or MLFS were defined in outcome measure #6. Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Up to 2 years |
| Duration of Complete Remission (DCR) (Cohorts 1 and 2) | DCR was measured from the time the assessment criteria were first met for CR (CRMRD- or CRMRD+/unk) until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. KM estimates were used in outcome measure analysis. | Up to 2 years |
| Duration of CR/CRi (Cohorts 1 and 2) | Duration of CR/CRi was measured from the time the assessment criteria were first met for CR (CRMRD- or CRMRD+/unk) or CRi until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. CRi was defined in outcome measure #6. KM estimates were used in outcome measure analysis. | Up to 2 years |
| Duration of CR/CRh (Cohorts 1 and 2) | Duration of CR/CRh was measured from the time the assessment criteria are first met for CR (CRMRD- or CRMRD+/unk) or CRh until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. CRh was defined in outcome measure #6. KM estimates were used in outcome measure analysis. | Up to 2 years |
| Event-Free Survival (EFS) (Cohorts 1 and 2) | EFS was defined as the time from the date of the first dose of study treatment to the earliest date of documented relapse from CR, treatment failure (defined as failure to achieve CR during the response assessment window (the first treatment dosing date until before the fifth cycle of magrolimab + venetoclax + azacitidine in Cohort 1 and the first treatment dosing date until before the third cycle of magrolimab + MEC in Cohort 2), or death from any cause within the response assessment window. Response assessments post SCT were included in the analysis. Deaths post SCT or new anti-AML therapies (except SCT and post SCT maintenance) were included. Those who were not observed to have one of these events during the study were censored at the date of their last response assessment during the study. Day 1 of treatment was assigned as the event date for participants with treatment failure. CR was defined in outcome measure #1. KM estimates were used in outcome measure analysis. | Up to 2 years |
| Relapse-Free Survival (RFS) Rate (Cohort 3) | RFS was defined as the time from the first dose of study treatment until the first date of AML relapse or death from any cause, whichever came first. | Up to 2 years |
| MRD Negative CR/CRi Rate (Cohort 3) | MRD negative CR/CRi rate was defined as the percentage of participants who maintained CR/CRi as determined by the investigator based on prespecified criteria and reach MRD negative disease status on 2 consecutive bone marrow assessments as determined using multiparameter flow cytometry with a sensitivity of < 0.1% while on study prior to initiation of any new anti-AML therapy. CR was defined in outcome measure #1. CRi was defined in outcome measure #6. | Up to 2 years |
| Duration of Minimal Residual Disease Negative Complete Remission (Cohort 3) | Duration of MRD negative CR was measured from the time the participant achieved MRD-negative status and maintained CR until the first date of AML relapse, loss of MRD negative status, or death (including assessments post SCT). CR was defined in outcome measure #1. | Up to 2 years |
| Duration of MRD Negative CR/CRi (Cohort 3) | Duration of MRD negative CR/CRi was measured from the time the participant achieved MRD-negative status (first of the 2 consecutive MRD negative bone marrow assessments) and maintained CR/CRi until the first date of AML relapse, loss of MRD negative status, or death (including assessments post SCT). CR was defined in outcome measure #1. CRi was defined in outcome measure #6. | Up to 2 years |
| Overall Survival (OS) (Cohorts 1, 2 and 3) | OS was measured from the date of the first dose of study treatment to the date of death from any cause. Those who were not observed to die during the study were censored at last date they were known to be alive. KM estimates were used in outcome measure analysis. | Up to 2 years |
| Red Blood Cell (RBC) Transfusion Independence Rate (Cohorts 1, 2 and 3) | RBC transfusion independence rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusion at any time between the date of the first dose and discontinuation of study treatment among all participants who were RBC transfusion-dependent at baseline. RBC transfusion independence rate was reported as 2 categories:
Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 2 years |
| Platelet Transfusion Independence Rate (Cohorts 1, 2 and 3) | Platelet transfusion independence 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 and discontinuation of study treatment among all participants who were platelet transfusion-dependent at baseline. Platelet transfusion independence rate was reported as 2 categories:
Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 2 years |
| Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) | Cohort 1: Predose: Days 1, 8, 29, 57, 113, 169, 253 and 337; Cohort 2: Days 1, 8, 29 and 57 |
| Percentage of Participants With Anti-Magrolimab Antibodies (Cohorts 1 and 2) | Percentages were rounded-off. | Up to 2 years |
| Levels of Anti-Magrolimab Antibodies (Cohorts 1 and 2) | Up to 2 years |
| Duarte |
| California |
| 91010 |
| United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | United States |
| Stanford Cancer Center | Palo Alto | California | 94305 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| OU Health, Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Froedtert Hospital & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Oxford University Hospitals NHS Foundation Trust, Churchill Hospital | Oxford | OX3 9DU | United Kingdom |
| FG001 | Safety Run-in Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| FG002 | Safety Run-in Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
| FG003 | Phase 2 Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine | Participants in Phase 2 Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) in 28-day cycles. Participants also received azacitidine 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years. |
| FG004 | Phase 2 Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Phase 2 Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| FG005 | Phase 2 Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Phase 2 Period |
|
|
The All-Enrolled Analysis Set included all participants who received a study patient identification (ID) number in the study after screening.
Per pre-specified analysis, the arms for both Cohorts 1 and 2 for Safety Run-in and Phase 2 periods were combined for analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Run-in Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine | Participants in Safety Run-in Cohort 1 with untreated AML who were unfit for chemotherapy received magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) for 28 days. Participants also received azacitidine 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28. |
| BG001 | Safety Run-in Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in Cohort 2 with R/R AML received magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV for 28 days. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for 28 days. |
| BG002 | Phase 2 Cohort 1 (1L, Unfit AML): Magrolimab + Venetoclax + Azacitidine | Participants in Phase 2 Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg over 2 hours Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV in 28-day cycles. Participants also received azacitidine 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9, SC or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years. |
| BG003 | Phase 2 Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Phase 2 Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Remission (CR) Rate (Cohorts 1 and 2) | CR rate was the percentage of participants who achieved CR (CR without minimal residual disease (CRMRD-) or complete remission with positive or unknown minimal residual disease (CRMRD+/unk)) as determined by the investigator based on prespecified criteria while on study prior to initiation of any new anti-cancer therapy. CRMRD- and CRMRD+/unk were 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. CRMRD- status as determined using multiparameter flow cytometry with a sensitivity of < 0.1%. Assessment of leukemia response in participants with acute myeloid leukemia (AML) were conducted based on the European Leukemia Net (ELN) recommendations for AML. Percentages were rounded-off. Clopper-Pearson method was used for outcome measure analysis. | The Full Analysis Set included all enrolled participants who received at least 1 dose of any study treatment, with treatment group designated according to the assigned treatment. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Minimal Residual Disease Negative Complete Remission Rate (Cohort 3) | The minimal residual disease (MRD) negative CR rate was defined as the percentage of participants who maintain CR as determined by the investigator based on prespecified criteria and reach MRD negative disease status on 2 consecutive bone marrow assessments, as determined using multiparameter flow cytometry with a sensitivity of < 0.1% while on study prior to initiation of any new anti-AML therapy. Assessment of leukemia response in participants with AML were conducted based on the ELN recommendations for AML. CR was defined in outcome measure #1. | As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) (Safety Run-in Cohorts 1, 2 and 3) | DLTs were defined as any Grade 4 or higher hematologic toxicity or Grade 3 or higher nonhematologic toxicity (that had worsened in severity from pretreatment baseline) during the 4-week DLT assessment period and was related to magrolimab or magrolimab combination. | The DLT Evaluable Analysis Set included all participants in the Safety Analysis Set who were enrolled in the Safety Run-in cohorts, have safety assessments through the protocol-specified DLT assessment window (first 4 weeks of study dosing, inclusive), and fulfill the criteria for evaluation for DLT specified in the protocol. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Number | percentage of participants | Up to 28 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Cohorts 1, 2 and 3) | TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dosing date or the day before initiation of new anticancer therapy including SCT, whichever comes first. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Percentages were rounded-off. | The Safety Analysis Set included all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Number | percentage of participants | First dose date up to 1.7 years plus 70 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities (Cohorts 1, 2 and 3) | Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 70 days or the day before initiation of any new anticancer therapy including SCT, whichever comes first. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment emergent. Percentages were rounded-off. | Participants in the Safety Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Number | percentage of participants | First dose date up to 1.7 years plus 70 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR was the percentage of participants who achieved CR (CRMRD- or CRMRD+/unk), CRi, CRh, PR, or MLFS as per investigator based on prespecified criteria before starting any new anti-AML therapy (including SCT). CRi and CRh were defined as neutrophils >0.5 x 10^9/L, platelets > 50 x 10^9/L (except residual neutropenia (<1.0 × 10^9/L) or thrombocytopenia (<100 × 109/L) for CRi) and bone marrow blasts <5%; Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. PR: Neutrophils >1.0 x 10^9/L, platelets >100 x 10^9/L, bone marrow blasts reduced to 5%-25%, and a ≥50% reduction from baseline. Blasts <5% with Auer rods may also be considered a PR. MLFS: Bone marrow blasts <5%, absence of circulating blasts or Auer rods, no extramedullary disease, marrow should not merely be "aplastic"; at least 200 cells or 10% cellularity, and no requirement for hematologic recovery. CR was defined in outcome measure #1. Percentages were rounded-off. | Participants in the Full Analysis Set were analyzed. Clopper-Pearson exact method was used in outcome measure analysis. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR/CRh) (Cohorts 1 and 2) | CR/CRh rate was the percentage of participants who achieved CR (CRMRD- or CRMRD+/unk) or CRh as determined by the investigator based on prespecified criteria while on study prior to initiation of any new anti-AML therapy (including SCT). CR was defined in outcome measure 1. CRh was defined in outcome measure 6. Percentages were rounded-off. Clopper-Pearson exact method was used in outcome measure analysis. | Participants in the Full Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) (Cohorts 1 and 2) | DOR was measured from the time assessment criteria that were met for CR (CRMRD- or CRMRD+/unk), CRi, CRh, PR, or MLFS, whichever was first recorded, until the first date of AML relapse, progressive disease, or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies.CR was defined in outcome measure #1. CRi, CRh, PR, or MLFS were defined in outcome measure #6. Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Participants in the Full Analysis Set who achieved overall response were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Complete Remission (DCR) (Cohorts 1 and 2) | DCR was measured from the time the assessment criteria were first met for CR (CRMRD- or CRMRD+/unk) until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. KM estimates were used in outcome measure analysis. | Participants in the Full Analysis Set who achieved CR were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CR/CRi (Cohorts 1 and 2) | Duration of CR/CRi was measured from the time the assessment criteria were first met for CR (CRMRD- or CRMRD+/unk) or CRi until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. CRi was defined in outcome measure #6. KM estimates were used in outcome measure analysis. | Participants in the Full Analysis Set who achieved CR/CRi were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CR/CRh (Cohorts 1 and 2) | Duration of CR/CRh was measured from the time the assessment criteria are first met for CR (CRMRD- or CRMRD+/unk) or CRh until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have a relapse, progressive disease, or death were censored at the date of their last response assessment. For participants who started taking new anti-AML therapies (except SCT and post SCT maintenance treatment) before relapse/PD/death, duration of response were censored at the last response assessment before the initiation of the new anti-AML therapies. CR was defined in outcome measure #1. CRh was defined in outcome measure #6. KM estimates were used in outcome measure analysis. | Participants in the Full Analysis Set who achieved CR/CRh were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) (Cohorts 1 and 2) | EFS was defined as the time from the date of the first dose of study treatment to the earliest date of documented relapse from CR, treatment failure (defined as failure to achieve CR during the response assessment window (the first treatment dosing date until before the fifth cycle of magrolimab + venetoclax + azacitidine in Cohort 1 and the first treatment dosing date until before the third cycle of magrolimab + MEC in Cohort 2), or death from any cause within the response assessment window. Response assessments post SCT were included in the analysis. Deaths post SCT or new anti-AML therapies (except SCT and post SCT maintenance) were included. Those who were not observed to have one of these events during the study were censored at the date of their last response assessment during the study. Day 1 of treatment was assigned as the event date for participants with treatment failure. CR was defined in outcome measure #1. KM estimates were used in outcome measure analysis. | Participants in the Full Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Relapse-Free Survival (RFS) Rate (Cohort 3) | RFS was defined as the time from the first dose of study treatment until the first date of AML relapse or death from any cause, whichever came first. | As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MRD Negative CR/CRi Rate (Cohort 3) | MRD negative CR/CRi rate was defined as the percentage of participants who maintained CR/CRi as determined by the investigator based on prespecified criteria and reach MRD negative disease status on 2 consecutive bone marrow assessments as determined using multiparameter flow cytometry with a sensitivity of < 0.1% while on study prior to initiation of any new anti-AML therapy. CR was defined in outcome measure #1. CRi was defined in outcome measure #6. | As no participants were enrolled in Cohort 3, data were not collected for this outcome measure. | Posted | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Minimal Residual Disease Negative Complete Remission (Cohort 3) | Duration of MRD negative CR was measured from the time the participant achieved MRD-negative status and maintained CR until the first date of AML relapse, loss of MRD negative status, or death (including assessments post SCT). CR was defined in outcome measure #1. | As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of MRD Negative CR/CRi (Cohort 3) | Duration of MRD negative CR/CRi was measured from the time the participant achieved MRD-negative status (first of the 2 consecutive MRD negative bone marrow assessments) and maintained CR/CRi until the first date of AML relapse, loss of MRD negative status, or death (including assessments post SCT). CR was defined in outcome measure #1. CRi was defined in outcome measure #6. | As no participants were enrolled in Cohort 3, data were not collected for this outcome measure. | Posted | Up to 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) (Cohorts 1, 2 and 3) | OS was measured from the date of the first dose of study treatment to the date of death from any cause. Those who were not observed to die during the study were censored at last date they were known to be alive. KM estimates were used in outcome measure analysis. | Participants in the Full Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Red Blood Cell (RBC) Transfusion Independence Rate (Cohorts 1, 2 and 3) | RBC transfusion independence rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusion at any time between the date of the first dose and discontinuation of study treatment among all participants who were RBC transfusion-dependent at baseline. RBC transfusion independence rate was reported as 2 categories:
Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants in the Full Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Platelet Transfusion Independence Rate (Cohorts 1, 2 and 3) | Platelet transfusion independence 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 and discontinuation of study treatment among all participants who were platelet transfusion-dependent at baseline. Platelet transfusion independence rate was reported as 2 categories:
Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants in the Full Analysis Set were analyzed. Per pre-specified analysis, the arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received the same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Magrolimab in Combination With Anti-leukemia Therapy (Cohorts 1, 2 and 3) | The Pharmacokinetic Analysis Set included all enrolled participants who received at least 1 dose of magrolimab and 1 measurable (non-below the limit of quantitation numeric values) post-treatment serum concentration of magrolimab. Participants with available data were analyzed. Per pre-specified analysis, arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Mean | Standard Deviation | μg/mL | Cohort 1: Predose: Days 1, 8, 29, 57, 113, 169, 253 and 337; Cohort 2: Days 1, 8, 29 and 57 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Magrolimab Antibodies (Cohorts 1 and 2) | Percentages were rounded-off. | The Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of magrolimab and have at least 1 reported anti-magrolimab antibody test result. Participants with post-baseline data were analyzed. Per pre-specified analysis, arms for Cohorts 1 and 2 for Safety Run-in and Phase 2 were combined for analysis as participants in Cohorts 1 and 2 received same dose. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected. | Posted | Number | percentage of participants | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Levels of Anti-Magrolimab Antibodies (Cohorts 1 and 2) | Participants in the Immunogenicity Analysis Set with post-baseline data were analyzed. Per Specified analysis, the arms for both Cohorts 1 and 2 for Safety Run-in and Phase 2 periods were combined for analysis. As no participants were enrolled in Cohort 3, data for Cohort 3 were not collected for this outcome measure. | Posted | Number | titer | Up to 2 years |
|
All-cause mortality: Up to 2 years; Adverse events: Up to 1.7 years plus 70 days
All-cause mortality: The All-Enrolled Analysis Set included all participants who received a study patient identification (ID) number in the study after screening.
Adverse events: The Safety Analysis Set included all participants who received at least 1 dose of study treatment, with treatment assignments designated according to the actual treatment received.
As no participants were enrolled in Cohort 3, data for adverse events were reported only for Cohorts 1 and 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (1L, Unfit AML): Safety Run-In Cohort: Magrolimab + Venetoclax + Azacitidine | Participants in Safety Run-in Cohort in Cohort 1 with untreated AML who were unfit for chemotherapy received magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 doses; 30 mg/kg over 2 hours every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose, intravenously (IV) for 28 days. Participants also received azacitidine 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9, subcutaneously (SC) or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28. | 5 | 7 | 7 | 7 | 7 | 7 |
| EG001 | Cohort 2 (R/R AML): Safety Run-In Cohort: Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in Cohort in Cohort 2 with R/R AML received magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV for 28 days. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for 28 days. | 6 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Cohort 1 (1L, Unfit AML): Phase 2 Cohort: Magrolimab + Venetoclax + Azacitidine | Participants in Phase 2 Cohort in Cohort 1 with untreated AML who were unfit for chemotherapy received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg over 2 hours Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV in 28-day cycles. Participants also received azacitidine 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9, SC or IV, along with venetoclax oral tablets, 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Days 3 to 28 of Cycle 1, 400 mg on Days 1 to 28 in Cycle 2 and consecutive cycles for every 28-day cycle. The treatment duration was up to a maximum of 1.7 years. | 5 | 11 | 11 | 11 | 11 | 11 |
| EG003 | Cohort 2 (R/R AML): Phase 2: Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Phase 2 Cohort in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. | 19 | 30 | 18 | 30 | 29 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 27.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Infusion related hypersensitivity reaction | Immune system disorders | 27.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Testicular abscess | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 27.0 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | 27.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 27.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | 27.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 27.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | 27.0 | Systematic Assessment |
| |
| Vitreous degeneration | Eye disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | 27.0 | Systematic Assessment |
| |
| Chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Chills | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | 27.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 27.0 | Systematic Assessment |
| |
| Pain | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Thirst | General disorders | 27.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatic infarction | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | 27.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Trichosporon infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | 27.0 | Systematic Assessment |
| |
| Haptoglobin decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Limb mass | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | 27.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Sleep terror | Psychiatric disorders | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | 27.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Jugular vein distension | Vascular disorders | 27.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 27.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2024 | Nov 13, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000629291 | magrolimab |
| D001374 | Azacitidine |
| C579720 | venetoclax |
| D008942 | Mitoxantrone |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| C000709231 | cc-486 |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001087 | Arabinonucleosides |
Not provided
Not provided
| Lost to Follow-up |
|
| Study Terminated By Sponsor |
|
| Withdrew Consent |
|
| >= 50 - < 75 Years |
|
| >= 75 Years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
|
|
Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
| OG001 | Cohort 2 (R/R AML): Magrolimab + MEC (Mitoxantrone + Etoposide + Cytarabine) | Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
Participants in Safety Run-in and Phase 2 Cohorts in Cohort 2 with R/R AML received the recommended dose of magrolimab, 1 mg/kg on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 doses; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose, IV up to 1.7 years. Participants also received MEC: mitoxantrone 8 mg/m^2 IV, etoposide 100 mg/m^2 IV and cytarabine 1000 mg/m^2 IV on Days 1 to 5 for three 28-day cycles. |
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|
| OG002 | Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486 | Participants with AML who achieved CR or CRi with intensive induction chemotherapy were to receive magrolimab along with CC-486. However, the cohort was closed before any participants could join, so no doses were given. |
|
|