Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myeloid Leukemia (AML)
  • Myelodysplastic Syndrome
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: 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 2 parts: phase 1 dose escalation and phase 2 dose expansion. Phase 1 Dose Escalation: Approximately 18 subjects with either relapsed/refractory (R/R) AML or R/R higher risk MDS will be enrolled. Participants will receive 2 single doses of ASP7517 via intravenous infusion. Dosi...

This study consists of 2 parts: phase 1 dose escalation and phase 2 dose expansion. Phase 1 Dose Escalation: Approximately 18 subjects with either relapsed/refractory (R/R) AML or R/R higher risk MDS will be enrolled. Participants will receive 2 single doses of ASP7517 via intravenous infusion. Dosing will occur on day 1 of each cycle. Each cycle is defined as 28 days with a total of 2 treatment cycles. Participants must be managed under hospitalization for at least 7 days during the first cycle of the dose escalation phase. In addition, prior to hospital discharge, participant safety must be ensured by performing medical tests and procedures listed on day 7 of cycle 1 and tests considered clinically necessary to evaluate the participant's general condition and adverse event (AE) resolution. The participant should also be followed on an outpatient basis on planned visits during cycles 1 and 2 after hospital discharge during the dose limiting toxicity (DLT) assessment period to closely monitor any AEs. Participants may be hospitalized days 1 to 7 during cycle 2. Phase 2 Dose Expansion: Approximately 104 participants per dose level will be enrolled. Each dose level may enroll up to 52 R/R AML participants and up to 52 R/R higher risk MDS participants. Both groups of participants will enroll in parallel and independently. The number of dose levels investigated during phase 2 will be based upon the data from phase 1. When escalation and expansion cohorts are both open for enrollment, enrollment into escalation cohorts takes priority such that participants who are eligible for both will be preferentially enrolled in the escalation cohorts.

Tracking Information

NCT #
NCT04079296
Collaborators
Not Provided
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.