VELCADE® Plus Rituximab in Non Hodgkin's Follicular Lymphoma

Conditions

• Non Hodgkin's Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Bortezomib (VELCADE) — DRUG
  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.
• Rituximab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Aug 31, 2006

Status verified

Apr 2013

Primary completion

Aug 31, 2008

Completion

May 31, 2011

Study Design

Enrollment

45 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bortezomib + Rituximab
  Single arm. Patients will be treated with Bortezomib, 1,3 mg/m2 intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of 21 day cycle for 6 cycles and Rituximab 375 mg/m2 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.

Primary Outcome Measure

Antitumor activity after complete treatment [ Time Frame: 30 days after the last infusion of rituximab ]