Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01849263|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2013
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Refractory Follicular Lymphoma||Drug: Ibrutinib Other: Laboratory Biomarker Analysis||Phase 2|
I. Evaluate the overall response rate of ibrutinib in patients with relapsed or refractory follicular lymphoma.
I. Assess the safety and tolerability of ibrutinib in patients with follicular lymphoma.
II. Evaluate overall survival, time to response, duration of response, progression-free survival, time to treatment failure, and time to subsequent treatment.
I. Describe the relationship between interim positron emission tomography (PET)/computed tomography (CT) scan results, CT response, and response duration.
II. Biomarker studies including exploring associations between ibrutinib response and somatic mutations identified in follicular lymphoma, whole transcriptome shotgun sequencing (ribonucleic acid-sequencing [RNA-seq]), exploration of inhibition of Bruton's tyrosine kinase (BTK) and other kinases, expression of cytokines, chemokines, and other proteins with an aim to develop predictors of response and resistance.
III. Assess changes in various cancer-derived molecules in the blood over the course of treatment with ibrutinib.
IV. As part of ongoing research for Phase II Consortium (P2C) studies, we are banking paraffin-embedded tissue blocks/slides and blood products for future studies.
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 3 months until progressive disease, and then every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Trial of Single-Agent Ibrutinib (PCI-32765) in Relapsed or Refractory Follicular Lymphoma|
|Study Start Date :||April 2013|
|Primary Completion Date :||October 2016|
Experimental: Treatment (ibrutinib)
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease at the end of course 2 may continue on therapy until the end of course 5 at the discretion of the treating physician.
Other Names:Other: Laboratory Biomarker Analysis
- Overall response rate defined as a partial response (PR) or complete response (CR) as the objective status at any time during treatment, evaluated using the Cheson et al. Revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to 5 years ]Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.
- Duration of response [ Time Frame: Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 5 years ]Estimated using the method of Kaplan-Meier.
- Overall survival [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ]Estimated using the method of Kaplan-Meier.
- Progression-free survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 5 years ]Estimated using the method of Kaplan-Meier.
- Time to response [ Time Frame: Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR, assessed up to 5 years ]The median and range will be reported.
- Time to subsequent treatment [ Time Frame: Time from registration to the date of initiation of subsequent treatment for lymphoma, assessed up to 5 years ]Estimated using the method of Kaplan-Meier.
- Time to treatment failure [ Time Frame: Time from registration to the date of treatment discontinuation due to any reason, assessed up to 5 years ]Estimated using the method of Kaplan-Meier.
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): NCT01849263
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Metro Minnesota Community Oncology Research Consortium|
|Saint Louis Park, Minnesota, United States, 55416|
|Park Nicollet Clinic - Saint Louis Park|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|National University Hospital Singapore|
|Singapore, Singapore, 119074|
|National Cancer Centre|
|Singapore, Singapore, 169610|
|Principal Investigator:||Nancy Bartlett||Mayo Clinic|