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

Acute Myeloid Leukemia Clinical Trial

Official title: 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Status Withdrawn

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT05829434
• Study type: Interventional
• Source: University of Leipzig
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 31, 2024
• Completion date: August 30, 2029