Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Myeloid Malignancies
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: After completion of Safety Run-in cohorts and identification of the RP2D for the specific cohorts, participants will be enrolled to the corresponding Phase 2 cohorts.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study consists of 3 safety run-in cohorts; Safety Run-in Cohort 1 (Mag + Ven + Aza) Safety Run-in Cohort 2 (Mag + MEC) Safety Run-in Cohort 3 (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 co...

This study consists of 3 safety run-in cohorts; Safety Run-in Cohort 1 (Mag + Ven + Aza) Safety Run-in Cohort 2 (Mag + MEC) Safety Run-in Cohort 3 (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 will be enrolled into the corresponding Phase 2 cohorts; Phase 2 Cohort 1 (Mag + Ven + Aza) Phase 2 Cohort 2 (Mag + MEC) Phase 2 Cohort 3 (Mag + CC-486) Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts.

Tracking Information

NCT #
NCT04778410
Collaborators
Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences