Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2024

Primary Completion Date

August 30, 2028

Study Completion Date

August 30, 2029

Conditions
Acute Myeloid LeukemiaMyelodysplastic Neoplasm
Interventions
DRUG

Magrolimab

Patients will receive magrolimab on day 1; 4: IV 1 mg/kg; day 8: IV 15 mg/kg; day 11, 15 and 22: IV 30 mg/kg (plus 30 mg/kg for 5 weeks weekly and then q2w until the end of consolidation)

DRUG

7+3

"Patients will receive during Induction cycle 1: cytarabine at 100 mg/m² on study days 1-7 as a continuous infusion over 22-24 hours and daunorubicin at 60 mg/m² on study days 3, 4, 5~* optional during Induction cycle 2: cytarabine at 100 mg/m² on days 1-7 of the second induction cycle (i.e. study days 29-35) as a continuous infusion over 22-24 hours and daunorubicin at 60 mg/m² on days 3, 4, 5 of the second induction cycle (i.e. study days 31, 32, 33)~* optional during Consolidation cycle: cytarabine at 1 g/m² administered on days 1, 3, 5 of each consolidation cycle as an infusion for 2 hours every 12 hours (for patients \< 60 years up to 3 CONS cycles and for patients ≥ 60 years up to 2 CONS cycles)"

DRUG

CPX-351

"Patients will receive during Induction cycle 1: CPX-351 with daunorubicin 44 mg/m² and cytarabine 100 mg/m² on days 1, 3, 5~* optional during Induction cycle 2: CPX-351 with daunorubicin 44 mg/m² and cytarabine 100 mg/m² on days 29 + 30~* optional during Consolidation cycle: CPX-351 with daunorubicin 29 mg/m² and cytarabine 65 mg/m² on days 1, 3"

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Uwe Platzbecker

OTHER

NCT05829434 - Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS | Biotech Hunter | Biotech Hunter