Debio 1562M for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization).The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
Are You a Good Fit for This Trial?
This trial is for adults with Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome who have not responded to other treatments. Participants must be in relatively stable condition, with an ECOG performance status of ≤2, and have resolved any previous treatment-related issues to a mild level. Those who've had bone marrow transplants can join if they meet certain conditions regarding recovery time and absence of graft versus host disease.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Dose Escalation
Participants receive Debio 1562M intravenously in escalating doses every 3 weeks during each 21-day treatment cycle
Phase 1: Dose Optimization
Participants are randomized to receive one of the 2 selected doses from Phase 1 for further investigation and selection of recommended dose for Phase 2
Phase 2
Participants receive the recommended dose of Debio 1562M intravenously every 3 weeks during each 21-day treatment cycle to evaluate antileukemic activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Debio 1562M
Find a Clinic Near You
Who Is Running the Clinical Trial?
Debiopharm International SA
Lead Sponsor