Therapy with obinutuzumab for patients with lymphoma
Completed
- Conditions
- rituximab-refractory follicular lymphomain Dutch: rituximab-refractair folliculair lymfoom
- Registration Number
- NL-OMON26469
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
•Biopsy-proven rituximab refractory follicular lymphoma (defined as disease progression while on rituximab maintenance therapy). Patients are required to have received a minimum of 2 infusions of rituximab maintenance therapy and/or be on a maintenance schedule for a minimum of 3 months (measured from the time of first maintenance infusion). Disease progression must have occurred before the last maintenance infusion.
•No clinical or pathological evidence of transformation to high-grade or diffuse large B-cell lymphoma (e.g. B symptoms, fast-growing tumour, or increasing lactate dehydrogenase level)
Exclusion Criteria
•Known central nervous system involvement
•Concurrent use of other anti-cancer agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Overall response using the Revised Response Criteria for Malignant Lymphoma (RRMCML) for disease assessment (10)
- Secondary Outcome Measures
Name Time Method •Progression-free survival<br /><br>•Overall survival<br /><br>•Duration of response, in responders<br /><br>•Duration of stable disease<br /><br>•Time to next anti-lymphoma treatment<br /><br>•The detection of tumour lesions employing contrast enhanced CT-scan <br /><br>•The detection of tumour lesions employing 18F-FDG-PET<br /><br>•The detection of tumour lesions employing 89Zr-obinutuzumab immuno-PET<br /><br>•The detection of 89Zr-obinutuzumab in normal tissue<br /><br>•The description of safety data: all adverse events and serious adverse events (AEs/SAEs) according to to the NCI CTCAE v.4.<br>