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

NCT02771197 | Completed Phase 2 Results

• 1 other identifier: NSH 1150
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Number of Patients With 2-year Relapse Risk

  Hypothesis is that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse risk will decrease to ≤35%

  2 years

Secondary Outcomes (1)

• Assess Safety of Pembrolizumab by Recording the Number of Participants With Treatment-related Adverse Events

  6 months

Study Arms (1)

Lymphodepletion plus Pembrolizumab

EXPERIMENTAL

Fludarabine \& Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.

Drug: Fludarabine; Drug: Melphalan; Drug: Pembrolizumab

Interventions

Fludarabine DRUG

Lymphodepletion plus Pembrolizumab

Melphalan DRUG

Lymphodepletion plus Pembrolizumab

Pembrolizumab DRUG

Lymphodepletion plus Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Related Publications (24)

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• Solomon SR, Solh M, Morris LE, Holland HK, Bachier-Rodriguez L, Zhang X, Guzowski C, Jackson KC, Brown S, Bashey A. Phase 2 study of PD-1 blockade following autologous transplantation for patients with AML ineligible for allogeneic transplant. Blood Adv. 2023 Sep 26;7(18):5215-5224. doi: 10.1182/bloodadvances.2023010477.

  PMID: 37379271 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabine; Melphalan; pembrolizumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Scott Solomon
• Organization: The Blood and Marrow Transplant Group of Georgia/Northside Hospital

ssolomon@bmtga.com

404-255-1930

Study Officials

• Scott Solomon, MD

  Blood and Marrow Transplant Group of Georgia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 13, 2016
• Study Start: September 28, 2016
• Primary Completion: August 3, 2022
• Study Completion: July 31, 2023
• Last Updated: September 28, 2023
• Results First Posted: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)