Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05829434
Brief 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
Study:
NCT05829434
Study Brief:
Protocol Section:
NCT05829434