Recurrent Grade 1 Follicular Lymphoma Clinical Trial
Official title:
Phase 2 Trial of Single-Agent Ibrutinib (PCI-32765) in Relapsed or Refractory Follicular Lymphoma
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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