Minimal Residual Disease Clinical Trial
Official title:
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
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.
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.
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