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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Follicular

Treatments: Drug: Prednisolone, Prednisone or equivalent; Drug: Vincristine; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Ofatumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494780

111775

The MUNIN trial

Hx-CD20-409 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Active Comparator 1

Active Comparator group

Description:

Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg

Treatment:

Drug: Ofatumumab

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Prednisolone, Prednisone or equivalent

Drug: Vincristine

Active Comparator 2

Active Comparator group

Description:

Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg

Treatment:

Drug: Ofatumumab

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Prednisolone, Prednisone or equivalent

Drug: Vincristine