Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 78 |
| Updated: | 12/12/2018 |
| Start Date: | September 28, 2016 |
| End Date: | June 30, 2021 |
| Contact: | Scott Solomon, MD |
| Email: | ssolomon@bmtga.com |
| Phone: | 404-255-1930 |
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
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.
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.
Non-favorable risk AML patients will undergo a preparative regimen of lymphodepletion of
Flu/Mel followed by autologous transplantation. Anti-PD-1 therapy of pembrolizumab will begin
on Day +1 following stem cell transplantation and will be administered every 3 weeks for a
total of 8 doses. According to the literature, the risk of 2-year relapse is estimated to be
60-80% in patients with non-favorable risk AML in CR-1. With this protocol, investigators
hypothesize that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse
risk will decrease to less than or equal to 35%. The one-sided Wald test at 5% significance
level will be used to test the hypothesis. The size of 20 patients yields the power of 90.5%
assuming that the actual 2-year leukemia-free survival is 60%.
Flu/Mel followed by autologous transplantation. Anti-PD-1 therapy of pembrolizumab will begin
on Day +1 following stem cell transplantation and will be administered every 3 weeks for a
total of 8 doses. According to the literature, the risk of 2-year relapse is estimated to be
60-80% in patients with non-favorable risk AML in CR-1. With this protocol, investigators
hypothesize that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse
risk will decrease to less than or equal to 35%. The one-sided Wald test at 5% significance
level will be used to test the hypothesis. The size of 20 patients yields the power of 90.5%
assuming that the actual 2-year leukemia-free survival is 60%.
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
We found this trial at
2
sites
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Scott Solomon, MD
Phone: 404-255-1930
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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