Clinical trial: Ofatumumab + Dexamethasone

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BlankOfatumumab Added to Dexamethasone in Subjects With Relapsed or Refractory

Chronic Lymphocytic Leukemia

This study is not yet open for participant recruitment.

Verified by Brno University Hospital, May 2010

First Received: March 7, 2011 Last Updated: March 11, 2011 History of

Changes

Sponsor: Brno University Hospital

Collaborators: University Hospital Hradec Kralove

Faculty Hospital Kralovske Vinohrady

General Teaching Hospital, Prague

Information provided by: Brno University Hospital

ClinicalTrials.gov Identifier: NCT01310101

Purpose

The rationale of the study is to explore the safety and efficacy of ofatumumab

in combination with dexamethasone (O-dex regimen) in patients with

refractory/relapsed CLL. Moreover, the hypothesis is that this approach will be

able to achieve at least the same response rates compared with R-dex regimens

(historical controls; manuscript submitted to Leukemia), while maintaining lower

toxicity profile.

Condition Intervention Phase

Chronic Lymphocytic Leukemia

Drug: ofatumumab plus dexamethasone

Phase II

Study Type: Interventional

Study Design: Allocation: Non-Randomized

Control: Uncontrolled

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Single Group Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title: Ofatumumab Added to Dexamethasone in Subjects With

Relapsed or Refractory Chronic Lymphocytic Leukemia

Full story:

http://clinicaltrials.gov/ct2/show/NCT01310101