Relapsed and refractory follicular non-Hodgkins Lymphoma (R/R FL) MedDRA version: 20.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: ABT-199 (GDC-0199)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ABT-199 (GDC-0199) 100 mg
Current Sponsor code: ABT-199
Concentration unit: mg milligram(s)
Concentration
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of GDC-0199 plus Bendamustine and Rituximab (BR) compared with BR alone in patients with R/R FL. 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall response rate (OR); Duration of response (DOR); Progression-free survival (PFS); Event-free survival (EFS); Overall survival (OS); ;Timepoint(s) of evaluation of this end point: Q4 2017 | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed