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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Lymphoma, Large-Cell, Diffuse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ofatumumab

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

Group Type EXPERIMENTAL

Ofatumumab

Intervention Type DRUG

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

Interventions

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Ofatumumab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No