Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778410
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2021-02-22
Brief Title:
Study of Magrolimab Combinations in Participants With Myeloid Malignancies
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Myeloid Malignancies
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05627466
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
The goal of this clinical study is to learn more about the safety and dosing of the study drug magrolimab Mag in combination with anti-leukemia therapies in participants with acute myeloid leukemia AML
Detailed Description:
The anti-leukemia therapies are defined as follows
Venetoclax Ven
Azacitidine Aza
Mitoxantrone etoposide and cytarabine MEC
This study consists of 3 safety run-in cohorts
Safety Run-in Cohort 1 1L Unfit AML Mag Ven Aza
Safety Run-in Cohort 2 RR AML Mag MEC
Safety Run-in Cohort 3 Post-chemo Maintenance Mag CC-486
Participants will receive treatment at the assigned dose level for at least 4 cycles in the Safety Run-in cohorts after which they may continue at the assigned dose level or switch to the RP2D upon agreement between the investigator and the sponsor After completion of each safety run-in cohort and identification of the RP2D for that cohort participants may be enrolled into the corresponding Phase 2 cohorts
Phase 2 Cohort 1 1L Unfit AML Mag Ven Aza
Phase 2 Cohort 2 RR AML Mag MEC
Phase 2 Cohort 3 Post-chemo Maintenance Mag CC-486
Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts
Note All cohorts are closed to screening and enrollment
Venetoclax Ven
Azacitidine Aza
Mitoxantrone etoposide and cytarabine MEC
This study consists of 3 safety run-in cohorts
Safety Run-in Cohort 1 1L Unfit AML Mag Ven Aza
Safety Run-in Cohort 2 RR AML Mag MEC
Safety Run-in Cohort 3 Post-chemo Maintenance Mag CC-486
Participants will receive treatment at the assigned dose level for at least 4 cycles in the Safety Run-in cohorts after which they may continue at the assigned dose level or switch to the RP2D upon agreement between the investigator and the sponsor After completion of each safety run-in cohort and identification of the RP2D for that cohort participants may be enrolled into the corresponding Phase 2 cohorts
Phase 2 Cohort 1 1L Unfit AML Mag Ven Aza
Phase 2 Cohort 2 RR AML Mag MEC
Phase 2 Cohort 3 Post-chemo Maintenance Mag CC-486
Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts
Note All cohorts are closed to screening and enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| 2021-003833-13 | EUDRACT_NUMBER | None | None |