Pembrolizumab in Treating Minimal Residual Disease in Patients With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT02767934|
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|B Acute Lymphoblastic Leukemia Minimal Residual Disease Recurrent Acute Lymphoblastic Leukemia T Acute Lymphoblastic Leukemia||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To evaluate the efficacy of pembrolizumab in minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL).
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.
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 13, 2017|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||April 1, 2021|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab 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.
Other: Laboratory Biomarker Analysis
- Rate of complete minimal residual disease response [ Time Frame: Up to 2 years ]Will be defined as percentage of evaluable subjects who achieve a complete response. Will be evaluated with a Simon two-stage optimum design.
- Incidence of adverse events [ Time Frame: Up to 2 years ]Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment.
- Overall Survival [ Time Frame: Up to 2 years ]
- Relapse-Free Survival [ Time Frame: Up to 2 years ]
- Changes in circulating peripheral blood mononuclear cells [ Time Frame: From baseline (at screening) to end of treatment ]Using a flow cytometry platform, relative proportions of circulating T-cell subsets and other components of cellular immunity can be quantified and compared pre- and post-treatment with pembrolizumab.
- Changes in circulating serum cytokines [ Time Frame: From baseline (at screening) to end of treatment ]Using a flow cytometry platform, relative proportions of circulating T-cell subsets and other components of cellular immunity can be quantified and compared pre- and post-treatment with pembrolizumab.
- Use of next-generation sequencing-based platform as a method of minimal residual disease detection [ Time Frame: From baseline (at screening) to end of treatment ]Compare disease assessments using next-generation sequencing to assessments using multiparameter flow cytometry and polymerase chain reaction.
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): NCT02767934
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ryan D. Cassaday 206-606-1202 firstname.lastname@example.org|
|Principal Investigator: Ryan D. Cassaday|
|Principal Investigator:||Ryan Cassaday||Fred Hutch/University of Washington Cancer Consortium|