Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-23 @ 2:15 PM
Study NCT ID:
NCT02767934
Status:
TERMINATED
Last Update Posted:
2020-08-20
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pembrolizumab in Treating Minimal Residual Disease in Patients With Acute Lymphoblastic Leukemia
Sponsor:
University of Washington
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-00602 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 9458 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |
| RG1016006 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View |