A double-blind, randomized, two-dose-arm, parallel group, international, multi-center trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with Follicular Lymphoma who are refractory to rituximab in combination with chemotherapy
Phase 3
- Conditions
- Folliculair LymphomaLymphnode Cancer10025320
- Registration Number
- NL-OMON29878
- Lead Sponsor
- Genmab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
diagnosis of Follicular Lymphoma grade 1* 2 refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment
Exclusion Criteria
The most important exclusion criteria consist of allogenic stem cell transplantation at any time, autologous stem cell transplantation within 6 months prior to Visit 1, more than 1 previous cycle of radio immunotherapy, anticancer therapy or corticosteroid therapy within 4 weeks prior to Visit 1 or known or suspected transformation of the follicular lymphoma to aggressive lymphoma unless new biopsy confirms FL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective response as measured over a 6 month period from start of treatment<br /><br>assessed by an Independent endpoints Review Committee (IRC) according to<br /><br>the standardized response criteria for Non-Hodgkin*s Lymphomas.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Duration of response<br /><br>2. Progression Free Survival (PFS)<br /><br>3. Time to next FL therapy<br /><br>4. Overall survival<br /><br>5. Reduction in tumor size<br /><br>6. CD19+ and CD20+ cells in peripheral blood<br /><br>7. Conversion from BCL2 positive to BCL2 negative in peripheral blood (by PCR)<br /><br>8. Prognostic value of Fc *receptor polymorphism, FLIPI (Follicular<br /><br>Lymphoma International Prognostic Index) and C1qA-276 mutation<br /><br>9. Adverse Events<br /><br>10. Human Anti Human Antibodies (HAHA)<br /><br>11. Complement: CH50<br /><br>12. Pharmacokinetic (PK) profile: AUC, Cl, Cmax, Cmin, Tmax, T*, Vz</p><br>