A Clinical Study of Rituximab with Ibrutinib Compared to Rituxumab Alone, and Subsequently of Ibrutinib Alone Compared to Placebo in Treatment Naïve Subjects with Follicular Lymphoma
- Conditions
- Follicular lymphomaMedDRA version: 24.0Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003202-14-GR
- Lead Sponsor
- Pharmacyclics LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
* Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
* Measurable disease
* Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
* Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Adequate hematologic function within protocol-defined parameters.
* Adequate hepatic and renal function within protocol-defined parameters.
* ECOG performance status score of 0-2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
* Transformed lymphoma
* Prior treatment for follicular lymphoma
* Central nervous system lymphoma or leptomeningeal disease
* Currently active, clinically significant cardiovascular disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method