Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Gilead Sciences
Study ID
NCT04778410
Phase
PHASE2
Status
Terminated

Conditions

  • Myeloid Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magrolimab — DRUG
    Administered intravenously
  • 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

Study Details

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).

Key Dates

Start date
Jun 28, 2021
Status verified
Feb 2025
Primary completion
Mar 4, 2024
Completion
Mar 4, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (1L Unfit AML): Magrolimab + Venetoclax + Azacitidine
    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.
  • Experimental: Cohort 2 (R/R AML): Magrolimab + Mitoxantrone + Etoposide + Cytarabine
    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.
  • Experimental: Cohort 3 (Post-Chemo Maintenance): Magrolimab + CC-486
    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.

Primary Outcome Measure

Complete Remission (CR) Rate (Cohorts 1 and 2) [ Time Frame: Up to 2 years ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford Cancer CenterPalo AltoCalifornia94305-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
The University of Chicago Medical CenterChicagoIllinois60637-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of MedicineSt LouisMissouri63110-
Roswell Park Cancer InstituteBuffaloNew York14263-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Cleveland Clinic FoundationClevelandOhio44195-
OU Health, Stephenson Cancer CenterOklahoma CityOklahoma73104-
Baylor University Medical CenterDallasTexas75246-
MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CACedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute· Los Angeles, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Center· Palo Alto, CASylvester Comprehensive Cancer Center· Miami, FL

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