Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02767934
Study type Interventional
Source University of Washington
Contact
Status Terminated
Phase Phase 2
Start date January 13, 2017
Completion date December 17, 2019

See also
  Status Clinical Trial Phase
Terminated NCT04044560 - Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant Phase 2
Recruiting NCT05959720 - Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Active, not recruiting NCT02458014 - Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease Phase 2
Active, not recruiting NCT03233854 - CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Active, not recruiting NCT04853017 - A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Phase 1
Not yet recruiting NCT06358430 - Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) Phase 1
Not yet recruiting NCT05603156 - A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive N/A
Withdrawn NCT03699384 - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD) Phase 1/Phase 2
Recruiting NCT05601830 - Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease Phase 1
Recruiting NCT06066905 - A Study of Chidamide With AZA in MRD Positive AML After Transplant N/A
Terminated NCT03272633 - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies Early Phase 1
Recruiting NCT03241940 - Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies Phase 1
Completed NCT03096782 - Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma Phase 2
Completed NCT05093192 - Mobilising Tumour and Immune Cells Via Exercise in Chronic Lymphocytic Leukaemia N/A
Recruiting NCT06230185 - ctDNA Based MRD Testing for NAC Monitoring in TNBC
Recruiting NCT02400827 - Contamination of Ovarian Tissue by RT-PCR in Participants With Solid Tumors N/A
Recruiting NCT02400970 - Contamination of Testicle Tissue by RT-PCR in Participants With Solid Tumors N/A
Active, not recruiting NCT01894477 - Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Phase 2
Active, not recruiting NCT04920188 - Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)