A Randomized, Open Label Study of Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
- Conditions
- Indolent B-cell Non-Hodgkin’s Lymphoma
- Registration Number
- EUCTR2008-004177-17-GR
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 376
1.Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma and follicular lymphoma (FL) grades; 1, 2 and 3A defined according to WHO guidelines:
•Tumor verified to be CD20+ positive from a previous or current lymph node biopsy
•CT imaging in screening phase (based on local evaluation) showing 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or 1 clearly demarcated lesion with a largest diameter = 2.0 cm. CT imaging performed at screening as baseline image
2.Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen:
•Maintaining stable disease or failure to achieve PR to rituximab-based therapy. (CT imaging will support this finding, and will be performed at least 60 days after the last dose of rituximab-based therapy)
or,
•Disease progression while on rituximab-based therapy (e.g., includes 4 weekly courses of rituximab given at 6-month intervals [Hainsworth, 2005])
or,
•Disease progression in subjects with stable disease or better response to rituximab-based therapy <6 months of the last dose of rituximab
Note: Subjects must have received minimum of 4 rituximab infusions as monotheray or 3 infusions as part of a rituximab containing combination regimens.
3.ECOG Performance Status of 0, 1, or 2
4.Age = 18 years
5.Life expectancy of at least 6 months
6.Signed written informed consent prior to performing any study-specific procedures
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma as verified by biopsy confirmation [e.g. constitutional symptoms, poor performance status, fast growing tumor or increasing lactate dehydrogenase (LDH) level]
2.Previous allogeneic stem cell transplant
3.Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy in the last 6 months
4.Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla or to more than 3 vertebral bodies
5.High dose steroids = 100 mg prednisone/day (or equivalent) for 7 consecutive days, given as concomitant medication, within 3 months prior to randomization. No more than 10 mg prednisone daily at the time of randomization
6.Prior bendamustine treatment within 1 year of randomization not resulting in a CR or PR for at least 6 months
7.Prior treatment with anti-CD20 monoclonal antibody, if 1st dose was administered within 60 days prior to randomization. Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to randomization.
8.Known CNS involvement of indolent lymphoma
9.Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible*
10.Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, and active Hepatitis C
11.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extrasystoles or minor conduction abnormalities
12.History of significant cerebrovascular disease or event with significant symptoms or sequelae
13.Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical Monitor contraindicates participation this study
14.Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded**
15.Current active liver or biliary disease (subjects with Gilbert’s syndrome or asymptomatic gallstones, liver metastases related to indolent NHL or otherwise stable chronic liver disease per investigator assessment, are eligible)
16.Known HIV positive
17.Screening laboratory values:
•platelets < 100 x 10^9/L (unless due to indolent lymphoma involvement of the bone marrow)
•neutrophils < 1.5 x 10^9/L (unless due to indolent lymphoma involvement of the bone marrow)
•Serum creatinine > 1.5 times the institution’s upper limit of normal (ULN); subjects with a serum creatinine > 1.5 ULN will be eligible if the calculated creatinine clearance [Cockcroft, 1976] or creatinine clearance from a 24
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method