Status:
COMPLETED
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monothe...
Detailed Description
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patient with follicular lymphoma grade 1 - 2
- Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as:
- failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
- disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
- disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
- Tumor verified to be CD20+ positive from excisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:
- 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
- ECOG Performance Status of 0, 1, or 2
- Age ≥ 18 years
- Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out
- Exclusion Criteria
- Previous autologous stem cell transplantation within 6 months
- Previous allogeneic stem cell transplantation
- More than 1 previous radio immunotherapy regimen
- Received radio immunotherapy within 3 months
- Received any Anti-cancer treatment within 4 weeks
- Received monoclonal antibodies, other than rituximab within 3 months
- Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- Life expectancy less than 6 months
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00394836
Start Date
May 1 2007
End Date
September 1 2013
Last Update
January 29 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD