NCT02767934

Pembrolizumab in Treating Minimal Residual Disease in Patients With Acute Lymphoblastic Leukemia

A Phase II Study of Anti-PD-1 Antibody (MK-3475; Pembrolizumab) for the Treatment of Minimal Residual Disease in Adults With Acute Lymphoblastic Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pembrolizumab works in treating small amounts of cancer cells that remain after attempts to remove the cancer has been made in patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of pembrolizumab in minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL). SECONDARY OBJECTIVES: I. To describe the toxicity profile of pembrolizumab in patients with previously-treated ALL. II. To gain a preliminary assessment of how MRD response translates into relapse-free and overall survival. EXPLORATORY OBJECTIVES: I. To compare disease assessments by multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) to a newly-developed and more sensitive next generation sequencing (NGS)-based platform. II. To correlate response to pembrolizumab to immunologic markers in peripheral blood and bone marrow specimens. III. To evaluate if treatment with pembrolizumab has a measurable impact on hematopoietic engraftment and graft-vs-host disease (GVHD) in patients who subsequently undergo allogeneic hematopoietic cell transplantation (HCT). OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator. After completion of study treatment, patients are followed up every 3 months for up to 2 years.

Conditions

• B Acute Lymphoblastic Leukemia
• Minimal Residual Disease
• Recurrent Acute Lymphoblastic Leukemia
• T Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2017-01-13
• Primary completion: 2019-07-31
• Completion: 2019-12-17
• First posted: 2016-05-11
• Last updated: 2020-08-20
• Results posted: 2020-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study