Spots Global Cancer Trial Database for Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma
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Trial Identification
Brief Title: Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma
Official Title: Phase 2 Trial of Single-Agent Ibrutinib (PCI-32765) in Relapsed or Refractory Follicular Lymphoma
Study ID: NCT01849263
Study Description
Brief Summary: This phase II trial studies how well ibrutinib works in treating patients with follicular lymphoma that has come back after a period of improvement or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. Evaluate the overall response rate of ibrutinib in patients with relapsed or refractory follicular lymphoma. SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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. OUTLINE: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
National University Hospital Singapore, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
Contact Details
Name: Nancy L Bartlett
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR
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