Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Stopped early · Phase 3

Conditions studied: Lymphoma, Follicular

In brief

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Key facts

Study ID

NCT01077518

Run by

Novartis Pharmaceuticals

People needed

346

Starts

2010-08-26

Expected to finish

2018-12-26

Last updated by the study team

2020-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Indolent lymphoma including Grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage II. Tumor verified CD20+ and CT imaging done at screening verifying disease
• Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen
• Indolent lymphoma including grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass > 5 cm in any direction)
• ECOG Performance Status of 0, 1, or 2
• Life expectancy of at least 6 months
• 18 years or older
• Signed, written informed consent

You may not qualify if…

• Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma
• Previous allogeneic stem cell transplant
• Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy in the past 12 months
• Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two or to more than 3 vertebral bodies
• High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within 3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at the time of randomization
• Prior bendamustine treatment within 1 year of randomization not resulting in a CR or PR for at least 6 months
• Treatment with anti-CD20 monoclonal antibody within 3 months of randomization
• Known CNS involvement of indolent lymphoma
• Other past or current malignancy. Subjects free of malignancy for at least 5 years or have history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible
• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
• Clinically significant cardiac disease
• History of significant cerebrovascular disease or event with significant symptoms
• Positive serology for Hepatitis B
• Current active liver or biliary disease (except Gibber's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease)
• Known HIV positive
• Abnormal/inadequate blood values, liver and kidney function
• Current participation in other clinical study
• Inability to comply with the protocol activities
• Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Where it is running

• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Palm Springs, California, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Coeur d'Alene, Idaho, United States
• Novartis Investigative Site — Silver Spring, Maryland, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Mineola, New York, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Danville, Pennsylvania, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Richmond, Virginia, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Morgantown, West Virginia, United States
• Novartis Investigative Site — Capital Federal, Buenos Aires, Argentina
• Novartis Investigative Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Novartis Investigative Site — Derqui, Pilar, Buenos Aires, Argentina
• Novartis Investigative Site — La Plata, Buenos Aires, Argentina
• Novartis Investigative Site — Buenos Aires, Argentina
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Innsbruck, Austria
• Novartis Investigative Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.