Ibrutinib in Treating Patients With Relapsed or Refractory Transformed Indolent B-cell Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT02207062|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Indolent Adult Non-Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis||Not Applicable|
I. Perform a preliminary assessment of the efficacy of single-agent ibrutinib, based on overall response rate, in subjects with relapsed or refractory transformed indolent B-cell non-Hodgkin lymphoma (R/R TIL).
I. To determine the tolerability of chronic ibrutinib therapy in this patient population.
II. To determine the disease control rate of this regimen.
III. Evaluate the complete response rate, overall survival, and progression-free survival to single-agent ibrutinib in this patient population.
IV. Determine response rate relative to the underlying B-cell histology.
Patients receive ibrutinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Single-Agent Ibrutinib in Relapsed or Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Experimental: Treatment (ibrutinib)
Patients receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall response rate (combined complete response + partial response) [ Time Frame: Up to 5 years ]
- Complete response rate [ Time Frame: Up to 5 years ]
- Disease control rate [ Time Frame: Up to 5 years ]
- Overall survival [ Time Frame: Up to 5 years ]
- Progression-free survival [ Time Frame: Time from first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years ]Progression-free survival will be calculated using assessments by investigators. Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).
- Response rate relative to the underlying B-cell histology [ Time Frame: Up to 5 years ]
- Tolerability of chronic ibrutinib therapy [ Time Frame: Up to 5 years ]The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to classify and grade toxicities.
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): NCT02207062
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Ajay Gopal||Fred Hutch/University of Washington Cancer Consortium|