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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 : December 14, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Northside Hospital, Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Fludarabine Drug: Melphalan Drug: Pembrolizumab Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Lymphodepletion plus Pembrolizumab
Fludarabine & Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
Drug: Fludarabine
Drug: Melphalan
Drug: Pembrolizumab



Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771197


Contacts
Contact: Scott Solomon, MD 404-255-1930 ssolomon@bmtga.com
Contact: Stacey Brown 404-851-8238 stacey.brown@northside.com

Locations
United States, Georgia
Blood and Marrow Transplant Group of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott R. Solomon, MD    404-255-1930      
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott Solomon, MD    404-255-1930    ssolomon@bmtga.com   
Contact: Stacey Brown, BA    404-851-8238    stacey.brown@northside.com   
Principal Investigator: Scott Solomon, MD         
Sub-Investigator: H. Kent Holland, MD         
Sub-Investigator: Asad Bashey, MD, PHD         
Sub-Investigator: Lawrence E Morris, MD         
Sponsors and Collaborators
Northside Hospital, Inc.
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Scott Solomon, MD Blood and Marrow Transplant Group of Georgia

Publications of Results:

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT02771197     History of Changes
Other Study ID Numbers: NSH 1150
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Northside Hospital, Inc.:
AML

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
Fludarabine
Fludarabine phosphate
Melphalan
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists