Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation

NSH 1150

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.

2016-09-28

2022-08-03

2023-07-31

Completed

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-09-28