Phase 2
N=20
Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02771197 ↗Enrolled (actual)
20
Serious AEs
60.0%
Results posted
Sep 2023
Primary outcome: Primary: Number of Patients With 2-year Relapse Risk — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Melphalan (Drug); Pembrolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northside Hospital, Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With 2-year Relapse Risk |
10 | — |
| SECONDARY Assess Safety of Pembrolizumab by Recording the Number of Participants With Treatment-related Adverse Events |
9 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02771197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.