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

• Status: Terminated
• Trial end date: 2018-12-26
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Bendamustine Hydrochloride; Ofatumumab; Rituximab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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