Viewing Study NCT05829434



Ignite Creation Date: 2024-05-06 @ 6:54 PM
Last Modification Date: 2024-10-26 @ 2:57 PM
Study NCT ID: NCT05829434
Status: WITHDRAWN
Last Update Posted: 2024-02-12
First Post: 2023-03-22

Brief Title: Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS
Sponsor: Uwe Platzbecker
Organization: University of Leipzig

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Status: WITHDRAWN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 73 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 73 or CPX-351 at

Day 1 4 IV 1 mgkg
Day 8 IV 15 mgkg
Day 11 15 and 22 IV 30 mgkg
Followed by weekly doses for 5 weeks and then q2w until the end of consolidation

If 73

Induction cycle 1 IND 1
Cytarabine at 100 mgm² on study days 1-7 as a continuous infusion over 22-24 hours
Daunorubicin at 60 mgm² on study days 3 4 5
Induction cycle 2 IND 2 optional
Cytarabine at 100 mgm² on days 1-7 of the second induction cycle ie study days 29-35 as a continuous infusion over 22-24 hours
Daunorubicin at 60 mgm² on days 3 4 5 of the second induction cycle ie study days 31 32 33
Consolidation cycle CONS optional
Cytarabine at 1 gm² 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 mgm² and cytarabine 100 mgm² days 1 3 5
Induction cycle 2 IND 2 optional CPX-351 fixed combination daunorubicin 44 mgm² and cytarabine 100 mgm² days 1 3 ie study days 29 30
Consolidation cycle 1 CONS optional CPX-351 fixed combination daunorubicin 29 mgm² and cytarabine 65 mgm² days 1 3

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
EU Trial Number OTHER 2022-502040-13-00 None