Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases
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|ClinicalTrials.gov Identifier: NCT03498612|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Non-Hodgkin Lymphoma Follicular Lymphoma Indolent Non-Hodgkin Lymphoma Marginal Zone Lymphoma||Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Window Study of Pembrolizumab in Untreated B-Cell Non-Hodgkin Lymphoproliferative Diseases|
|Actual Study Start Date :||July 9, 2018|
|Estimated Primary Completion Date :||September 16, 2022|
|Estimated Study Completion Date :||September 16, 2024|
Experimental: Treatment (pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall response rate (complete response [CR] + partial response [PR] for follicular lymphoma and marginal zone lymphoma) [ Time Frame: Up to 5 years ]Measured by Lugano Criteria evaluated by positron emission tomography (PET)/computed tomography (CT) or CT or white blood cell count for chronic lymphocytic leukemia (CLL). The corresponding 95% two-sided confidence interval will be derived.
- Duration of response [ Time Frame: From the time by which the measurement criteria are met for CR or PR, whichever is recorded first, until death or the first date by which recurrent or progressive disease is objectively documented, assessed up to 5 years ]Kaplan Meier methodology will be used to estimate event-free curves.
- Progression-free survival [ Time Frame: From the first study drug administration to the first occurrence of lymphoma progression or death from any cause, assessed up to 5 years ]Data for subjects without disease progression or death will be censored at the date of the last tumor assessment. Kaplan-Meier methodology will be used to estimate the event-free curves.
- Time to next therapy [ Time Frame: From the time of first study drug administration until the date of the first subsequent therapy given to treat the indolent B-cell non-Hodgkin lymphoproliferative diseases, assessed up to 5 years ]
- Incidence of adverse events (AEs) [ Time Frame: Up to 30 days after last dose ]Safety summaries will include tabulations in the form of tables. The frequency of treatment-emergent AE's will be summarized. Additional AE summaries will include AE frequency by AE severity and relationship to the 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): NCT03498612
|Contact: Ajay K. Gopalfirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay K. Gopal 206-606-2037 email@example.com|
|Principal Investigator: Ajay K. Gopal|
|Principal Investigator:||Ajay K. Gopal||Fred Hutch/University of Washington Cancer Consortium|