A double-blind, randomized, two-dose-arm, parallel, 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 - HuMax-CD20 in FL patients refractory to rituximab

• Conditions: Follicular Limphoma; MedDRA version: 14.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-001433-17-IT
• Lead Sponsor: GLAXO SMITH KLINE RESEARCH & DEVELOPMENT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-01
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

The trial population will be comprised of patient with a diagnosis of Follicular Lymphoma grade 1 - 2 refractory to rituximab in combination with chemotherapy or to rituximab given as maintenance treatment. Follicular Lymphoma grade 1 - 2 is defined according to WHO guidelines (3) and is verified to be CD20+ positive from excisional lymph node biopsy. Refractory to rituximab in combination with chemotherapy (e.g. R-F, R-CVP, R-CHOP, R-FM, R-FCM), or to rituximab given as maintenance treatment, is defined as: 1. failure to achieve at least PR to rituximab in combination with chemotherapy; or, 2. disease progression while on rituximab (either in combination with chemotherapy or during rituximab maintenance treatment); or, 3. disease progression in responders within 6 months of the last dose of rituximab (either in combination with chemotherapy or after rituximab maintenance treatment schedule) The patients should be `?¥ 18 years of age and have given informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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 clinical trial of medicinal product
• Study Design: Not specified