Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Large-Cell, Diffuse

Treatments: Drug: Ofatumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622388

111776

GEN415 (Other Identifier)

Details and patient eligibility

About

The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with DLBCL

• and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
• and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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81 participants in 1 patient group

Ofatumumab

Experimental group

Description:

8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg

Treatment:

Drug: Ofatumumab