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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Follicular

Treatments

Drug: Ofatumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00394836

Hx-CD20-405 (Other Identifier)

111772 (Other Identifier)

Details and patient eligibility

About

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

Full 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 HuMax-CD20. Disease status will be assessed every 3 months until month 24.

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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