Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 10:20 AM
Study NCT ID:
NCT05829434
Status:
WITHDRAWN
Last Update Posted:
2024-02-12
First Post:
2023-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS
Sponsor:
Uwe Platzbecker
Organization:
Study Overview
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WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was stopped prematurely due to safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGROLIC
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EU Trial Number | OTHER | 2022-502040-13-00 | View |