HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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 Monotherapy or in Combination With Chemotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Ofatumumab; Rituximab

Criteria

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