Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Ofatumumab; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• Patient with Follicular Lymphoma (FL)

• Confirmed diagnosis of Follicular lymphoma

• 18 years or above

• Verbal and written information about the study

Exclusion Criteria:

• No previous treatment for Follicular Lymphoma

• Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma

• Several diseases such as malignancies etc.

• Screening laboratory values

• Current participation in any other interventional clinical study

• Breast feeding women or pregnant women

• Women of childbearing potential not willing to use adequate contraception