NCT05829434

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

Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed "ELN 2022 Intermediate or Adverse-risk" AML or High Risk MDS Patients Intended to Undergo Allogeneic Stem Cell Transplantation, a Phase 2, Single-arm, Open-Label Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Uwe Platzbecker · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Use of magrolimab in combination with standard intensive chemotherapy ("7+3" or CPX-351) in newly diagnosed "ELN 2022 intermediate or adverse-risk" AML or high risk MDS patients, who intend to undergo allogeneic stem cell transplantation

Detailed description

Patients will receive magrolimab in combination with "7+3" or CPX-351 at: * Day 1, 4: IV 1 mg/kg * Day 8: IV 15 mg/kg * Day 11, 15 and 22: IV 30 mg/kg * Followed by weekly doses for 5 weeks and then q2w until the end of consolidation If "7+3": * Induction cycle 1 (IND 1): * Cytarabine at 100 mg/m² on study days 1-7 as a continuous infusion over 22-24 hours * Daunorubicin at 60 mg/m² on study days 3, 4, 5 * Induction cycle 2 (IND 2, optional): * 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 * Daunorubicin at 60 mg/m² on days 3, 4, 5 of the second induction cycle (i.e. study days 31, 32, 33) * Consolidation cycle (CONS, optional): * 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) If CPX-351: * Induction cycle 1 (IND 1): CPX-351 (fixed combination daunorubicin 44 mg/m² and cytarabine 100 mg/m²) days 1, 3, 5 * Induction cycle 2 (IND 2, optional): CPX-351 (fixed combination daunorubicin 44 mg/m² and cytarabine 100 mg/m²) days 1, 3 (i.e. study days 29, 30) * Consolidation cycle 1 (CONS, optional): CPX-351 (fixed combination daunorubicin 29 mg/m² and cytarabine 65 mg/m²) days 1, 3

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-31
• Primary completion: 2028-08-30
• Completion: 2029-08-30
• First posted: 2023-04-25
• Last updated: 2024-02-12