A Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or GDC-0199 Plus Rituximab in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma
Conditions
Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular - Lymphoma, Non-Hodgkin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bendamustine Type: Drug
Name: GDC-0199; ABT-199; RO5537382 Type: Drug
Name: Rituximab [MabThera/Rituxan] Type: Drug
Overall Status
Recruiting
Summary
This open-label, international, multicenter study will investigate the safety and efficacy of GDC-0199 in combination with bendamustine plus rituximab (GDC-0199 + BR) compared with BR alone in patients with relapsed and refractory follicular Non-Hodgkin's lymphoma (fNHL), comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of GDC-0199 in combination with rituximab (GDC-0199 + R), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort for a given patient will be at the discretion of the investigator. The anticipated time on study treatment is approximately 24-52 weeks, depending on treatment arm.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients must have histologically confirmed follicular lymphoma (FL) of Grade 1, 2, or 3a

- Patients must have received at least one prior therapy for FL

- For patients potentially receiving chemotherapy: if the patient has received prior bendamustine, response duration must have been > 1 year

- At least one bi-dimensionally measurable lesion on imaging scan defined as > 1.5 cm in its longest dimension

- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2

- Adequate hematologic function

- For female patients of childbearing potential and male patients with female partners of childbearing potential, agreement to use highly effective contraception measures

- Confirmed availability of archival or freshly biopsied tumor tissue meeting protocol-defined specifications prior to study enrollment

Exclusion Criteria:

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products

- Contraindication to potential treatment agents

- Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Patients receiving corticosteroid treatment with
- Primary central nervous system (CNS) lymphoma

- Vaccination with live vaccines within 28 days prior to treatment

- Chemotherapy or other investigational therapy within five half-lives of a biologic agent with a minimum of 28 days prior to the start of Cycle 1

- History of other malignancy that could affect compliance with the protocol or interpretation of results

- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient

- 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)

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1

- Requires the use of warfarin

- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

- Presence of positive test results for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation)

- Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1 (HTLV-1)

- Pregnant or lactating

- Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1), other than for diagnosis
Locations
Mobile, Alabama, United States
Status: Recruiting
Tucson, Arizona, United States
Status: Recruiting
Los Angeles, California, United States
Status: Not yet recruiting
Austell, Georgia, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Recruiting
Chicago, Illinois, United States
Status: Not yet recruiting
Harvey, Illinois, United States
Status: Recruiting
Westwood, Kansas, United States
Status: Recruiting
Baltimore, Maryland, United States
Status: Not yet recruiting
Hackensack, New Jersey, United States
Status: Recruiting
Rochester, New York, United States
Status: Recruiting
Philadelphia, Pennsylvania, United States
Status: Not yet recruiting
Pittsburgh, Pennsylvania, United States
Status: Not yet recruiting
Pittsburgh, Pennsylvania, United States
Status: Not yet recruiting
Charlottesville, Virginia, United States
Status: Not yet recruiting
Richmond, Virginia, United States
Status: Recruiting
Morgantown, West Virginia, United States
Status: Recruiting
Adelaide, New South Wales, Australia
Status: Recruiting
Camperdown, New South Wales, Australia
Status: Not yet recruiting
Kogarah, New South Wales, New South Wales, Australia
Status: Recruiting
St. Leonards, New South Wales, Australia
Status: Not yet recruiting
Sydney, New South Wales, Australia
Status: Not yet recruiting
Waratah, New South Wales, Australia
Status: Recruiting
Douglas, Queensland, Australia
Status: Recruiting
Woolloongabba, Queensland, Australia
Status: Recruiting
Hobart, Tasmania, Australia
Status: Not yet recruiting
Clayton, Victoria, Australia
Status: Recruiting
Antwerpen, Belgium
Status: Recruiting
Brugge, Belgium
Status: Recruiting
Bruxelles, Belgium
Status: Recruiting
Edmonton, Alberta, Canada
Status: Recruiting
Kelowna, British Columbia, Canada
Status: Recruiting
Toronto, Ontario, Canada
Status: Not yet recruiting
Montreal, Quebec, Canada
Status: Not yet recruiting
Montreal, Quebec, Canada
Status: Not yet recruiting
Montreal, Quebec, Canada
Status: Recruiting
Saskatoon, Saskatchewan, Canada
Status: Not yet recruiting
Angers, France
Status: Recruiting
Clermont Ferrand cedex 1, France
Status: Recruiting
Creteil, France
Status: Not yet recruiting
Dijon, France
Status: Recruiting
Le Mans, France
Status: Recruiting
Montpellier, France
Status: Recruiting
Pierre Benite, France
Status: Recruiting
Chemnitz, Germany
Status: Recruiting
Dessau-Roßlau, Germany
Status: Recruiting
Dresden, Germany
Status: Recruiting
Essen, Germany
Status: Not yet recruiting
Jena, Germany
Status: Recruiting
Koeln, Germany
Status: Recruiting
Lübeck, Germany
Status: Recruiting
Mainz, Germany
Status: Recruiting
Muenchen, Germany
Status: Recruiting
Ulm, Germany
Status: Not yet recruiting
Wuerzburg, Germany
Status: Recruiting
Bologna, Emilia-Romagna, Italy
Status: Recruiting
Meldola, Emilia-Romagna, Italy
Status: Recruiting
Ravenna, Emilia-Romagna, Italy
Status: Recruiting
Rimini, Emilia-Romagna, Italy
Status: Recruiting
Bergamo, Lombardia, Italy
Status: Recruiting
Milano, Lombardia, Italy
Status: Recruiting
Pavia, Lombardia, Italy
Status: Not yet recruiting
Torino, Piemonte, Italy
Status: Recruiting
Firenze, Toscana, Italy
Status: Recruiting
Blackpool, United Kingdom
Status: Recruiting
Leeds, United Kingdom
Status: Recruiting
Leicester, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
Manchester, United Kingdom
Status: Recruiting
Oxford, United Kingdom
Status: Recruiting
Sutton, Surrey, United Kingdom
Status: Recruiting
Start Date
December 2014
Completion Date
March 2018
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page