Last updated: 11/03/2018 11:18:45
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Ofatumumab and Bendamustine Combination Therapy Compared with Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin’s Lymphoma (NHL) Unresponsive to Rituximab or a Rituximab-Containing RegimenCOMPLEMENT A+B
GSK study ID
110918
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: 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
Trial description: The purpose of this study is 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Progression-free-survival following ofatumumab and bendamustine combination therapy
Timeframe: 68 months
Secondary outcomes:
Overall response rate, overall survival, time to and duration of response following ofatumumab and bendamustine combination therapy
Timeframe: 62 months
Clinical benefit, changes in patient reported outcome measures, and pharmacokinetics following ofatumumab and bendamustine combination therapy
Timeframe: 62 months
Safety and tolerability of ofatumumab and bendamustine combination therapy
Timeframe: 62 months
Interventions:
Drug: Ofatumumab and Bendamustine infusions (Arm A)
Drug: Bendamustine infusion (Arm B)
Enrollment:
346
Observational study model:
Not applicable
Primary completion date:
2017-17-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lymphoma, Follicular
Product
ofatumumab
Collaborators
Not applicable
Study date(s)
August 2010 to July 2023
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 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
- Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma
- Previous allogeneic stem cell transplant
Inclusion and exclusion 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 Gibler'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
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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