Nivolumab for Relapsed or Refractory Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT04205409|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2019
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Chronic Lymphocytic Leukemia Recurrent Diffuse Large B-Cell Lymphoma Recurrent Follicular Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Grade 3a Follicular Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Non-Hodgkin Lymphoma Recurrent Plasma Cell Myeloma Refractory Chronic Lymphocytic Leukemia Refractory Diffuse Large B-Cell Lymphoma Refractory Follicular Lymphoma Refractory Marginal Zone Lymphoma Refractory Non-Hodgkin Lymphoma Refractory Plasma Cell Myeloma||Biological: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nivolumab for Relapsed or Refractory Disease Post Chimeric Antigen Receptor T-Cell Treatment in Patients With Hematologic Malignancies|
|Estimated Study Start Date :||April 3, 2020|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||August 1, 2022|
Experimental: Treatment (nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Best overall response rate (ORR) [ Time Frame: Up to 5 years ]Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided.
- Overall survival [ Time Frame: From the first study drug administration to death from any cause, up to 5 years ]Will employ Kaplan-Meier and Cox proportional hazard model methodology.
- Progression-free survival [ Time Frame: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years ]Will employ Kaplan-Meier and Cox proportional hazard model methodology.
- Duration of response [ Time Frame: Up to 5 years ]Will employ Kaplan-Meier and Cox proportional hazard model methodology.
- Incidence of adverse events [ Time Frame: Up to 30 days after the last dose of study drug ]Will be determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Safety data will be summarized descriptively. Adverse events will be summarized by severity, seriousness, and relationship to study drug.
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): NCT04205409
|Contact: Andrew Cowanemail@example.com|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Andrew Cowan||Fred Hutch/University of Washington Cancer Consortium|