Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant

• Status: Active, not recruiting
• Trial end date: 2023-08-03
• Target enrollment: 0
• Participant gender: All

Summary

AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem cell transplantation as a possible cure; however, many patients are not candidates for allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of available donors. Therefore, these patients are unable to receive the therapeutic benefits of the "graft-versus-leukemia" effect of donor immune cells. The aim of this study is to hopefully break immune tolerance to AML cells to provide better outcomes in patients with non-favorable risk AML.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northside Hospital, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Fludarabine; Fludarabine phosphate; Melphalan; Pembrolizumab

Criteria

Inclusion Criteria:

• Non-favorable risk AML

• In CR-1 or subsequent CR

• Completed at least one cycle of consolidation chemotherapy

• Collection of at least 2x106/kg CD34+ cells

• KPS of 70% or greater

Exclusion Criteria:

• Received investigational agent within 4 weeks of first dose

• Prior chemotherapy, radiation therapy within 2 weeks of first dose

• Hypersensitivity to pembrolizumab or any of its excipients

• Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent