NCT01830465

VELCADE® Plus Rituximab in Non Hodgkin's Follicular Lymphoma

Phase II Study of VELCADE in Combination With Rituximab in Patients With Relapsed or Progressed Non Hodgkin's Follicular Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Gruppo Italiano Studio Linfomi · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the efficacy and safety of the combination of Velcade and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.

Detailed description

Eligible patients will receive the combination Velcade-rituximab for up to a total of 6 cycles of Velcade and 6 infusion of rituximab. Patients will be evaluated for clinical, laboratory, imaging parameters at baseline, during study treatment, at the end of the treatment and during follow up (every 6 months for 3 years). In the first stage, 17 patients will be treated. An interim analysis will be performed after recruitment of the first 17 evaluable patients. Aim of this analysis is to determine preliminary the activity of the treatment.If \> 7 responses are observed, the accrual is continued and 24 additional patients are treated up to a total of 41. If ≤ 21 respond, the treatment is rejected as ineffective. If 22 or more respond, the treatment is judged promising for further development.

Conditions

• Non Hodgkin's Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Bortezomib (VELCADE)	1,3 mg/m2, intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of each 21 day cycle. Number of Cycles: 6.
DRUG	Rituximab	375 mg/m2 as intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI.

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-08-01
• Completion: 2011-05-01
• First posted: 2013-04-12
• Last updated: 2013-04-12

Locations

1 site across 1 country: Italy