NCT00136591

A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma. Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.

Detailed description

This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates therapy of Velcade™ in subjects who have relapsed or refractory follicular B-cell lymphoma (FLL). Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study. It is anticipated that approximatively 120 subjects will be enrolled to achieve the required 110 evaluable subjects, 55 in each treatment arm. Patients who receive any amount of Velcade™ are evaluable. Subjects not evaluable for response will be replaced. A central randomization will be used in this study. Subjects will be randomized and stratified with factors for prior therapies (1 or 2 versus \> 2) and time to progression (TPP) for the last given anti-neoplastic therapy (≤ 12 months versus \> 12 months). The eligible subjects will be randomized to either Treatment Arm A or Treatment Arm B in a 1:1 ratio: * Subjects randomized to Treatment Arm A will receive 1.5 mg/m² Velcade™ administered biweekly on Days 1, 4, 8, and 11 of a 21-day cycle. Patients will receive 8 cycles. The dose of Velcade™ received in schedule A will be 48 mg/m² over 24 weeks. * Subjects randomized to Treatment Arm B will receive 1.6 mg/m² Velcade™ administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle. Patients will receive 6 cycles. The dose of Velcade™ received in schedule B will be 38.4 mg/m² over 30 weeks. Two additional cycles may be administered if the patient shows improvement to PR after 8 or 6 cycles for arm A or B, respectively. Study drug dose and schedule reduction for toxicity will be allowed during the study. A two stage interim analysis will be conducted in each treatment arm to determine whether either of the 2 treatments lacks sufficient efficacy. The final analysis will be conducted when all subjects have had the opportunity to complete the 30 day post-treatment evaluation visit. All data from all visits up until this point will be used in the final analysis, including data from any follow-up visits that have occurred. Patients will be recruited approximately over 2 years and followed until all data are available for final analysis. The total duration of the study is expected to be 5 years.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Bortezomib	Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle
DRUG	Bortezomib	Arm B: a 35-day cycle of 1.6 mg/m2 Velcade™once weekly for 4 weeks. Days 1, 8, 15, and 22 of a 35-day cycle. Subjects in this treatment arm will receive a total of 6 cycles of treatment, approximately 30 weeks.

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2005-08-29
• Last updated: 2010-10-26

Locations

4 sites across 2 countries: Belgium, France