A PHASE II, OPEN-LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF GDC-0199 (ABT- 199) PLUS BENDAMUSTINE PLUS RITUXIMAB (BR)IN COMPARISON WITH BR ALONE OR GDC-0199 PLUS RITUXIMAB (R) IN PATIENTS WITH RELAPSED AND REFRACTORY FOLLICULAR NON-HODGKIN’S LYMPHOMA
- Conditions
- Relapsed and refractory follicular non-Hodgkins Lymphoma (R/R FL)MedDRA version: 19.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000576-26-DE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 163
- Age = 18 years;
- Patients must have histologically confirmed follicular lymphoma of Grade 1, 2, or 3a;
- Patients must have received at least one prior therapy for FL
- If the patient has received prior bendamustine, response duration must have been > 1 year;
- At least one bi-dimensionally measurable lesion
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66
- Contraindication to receive either rituximab or bendamustine;
- Primary CNS lymphoma;
- Chemotherapy or other investigational therapy within 5 half-lives of a biologic agent with a minimum of 28 days prior to the start of treatment;
- Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm);
- Requires the use of warfarin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of GDC-0199 plus Bendamustine and Rituximab (BR) compared with BR alone in patients with R/R FL. <br> To evaluate the efficacy of GDC-0199 plus rituximab in patients with Relapsed and Refractory Follicular non-hodgkins Lymphoma (R/R FL);Secondary Objective: To make a preliminary assessment of efficacy when GDC-0199 plus BR or GDC 0199 plus rituximab are administered in combination to patients with Relapsed and Refractory follicular non-hodgkins Lymphoma (R/R FL);Primary end point(s): PET-defined complete response (CR) rate;Timepoint(s) of evaluation of this end point: Q2 2017
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall response rate (OR); <br>Duration of response (DOR); <br>Progression-free survival (PFS); <br>Event-free survival (EFS); <br>Overall survival (OS); ;Timepoint(s) of evaluation of this end point: Q4 2017