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 : July 19, 2018
|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|
I. To gain a preliminary assessment of the efficacy of pembrolizumab as monotherapy for patients with untreated indolent B-cell non-Hodgkin lymphoproliferative diseases (iBCL) based on overall response rate (ORR) measured at the end of a 6-cycle treatment period.
I. To assess the safety and toxicity profile of pembrolizumab in patients with untreated iBCL.
II. To measure the efficacy of pembrolizumab used as monotherapy for patients with untreated iBCL by assessing clinical outcomes including complete response rate (CR), time to next therapy (TNT), progression-free survival (PFS), and the duration of response (DOR).
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants 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|
|Estimated Study Start Date :||October 9, 2018|
|Estimated Primary Completion Date :||March 14, 2020|
|Estimated Study Completion Date :||March 14, 2022|
Experimental: Treatment (pembrolizumab)
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 18 courses 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 PET/CT or CT or white blood cell count for 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, 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
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Ajay K. Gopal 206-606-2037|
|Principal Investigator: Ajay K. Gopal|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|