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

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ClinicalTrials.gov Identifier: NCT02771197
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Northside Hospital, Inc.

Tracking Information
First Submitted Date  ICMJE March 22, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE September 28, 2016
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
Estimate the 2-year relapse risk by collecting bone marrow biopsies at the following monthly time points after transplant: 1, 2, 3, 6, 12, 18, and 24 months [ Time Frame: 2 years ]
Hypothesis is that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse risk will decrease to ≤35%
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02771197 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
Assess safety of pembrolizumab by recording the number of participants with treatment-related adverse events [ Time Frame: 2 years ]
Assess safety of pembrolizumab in patients with AML following lymphodepleting chemotherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant
Official Title  ICMJE 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
Brief 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.
Detailed Description 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%.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Fludarabine
  • Drug: Melphalan
  • Drug: Pembrolizumab
Study Arms  ICMJE Experimental: Lymphodepletion plus Pembrolizumab
Fludarabine & Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
Interventions:
  • Drug: Fludarabine
  • Drug: Melphalan
  • Drug: Pembrolizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Scott Solomon, MD 404-255-1930 ssolomon@bmtga.com
Contact: Stacey Brown 404-851-8238 stacey.brown@northside.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02771197
Other Study ID Numbers  ICMJE NSH 1150
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Northside Hospital, Inc.
Study Sponsor  ICMJE Northside Hospital, Inc.
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Scott Solomon, MD Blood and Marrow Transplant Group of Georgia
PRS Account Northside Hospital, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP