Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation(CLL-X4 Trial)
The goal of the study is to investigate the safety and efficacy of a consequent anti-CD20
therapy with the antibody ofatumumab in the context of allogeneic HCT. Allogeneic HCT itself
is not a study intervention and is triggered by the availability of an HLA-compatible stem
cell donor. The study is divided into an induction part and a maintenance part. During
induction where the antibody is combined with high dose dexamethasone, the main goal is to
reduce the tumor load prior to allogeneic HCT. Patients who achieved disease control (CR, PR
and SD) by the antibody proceed to maintenance therapy with the antibody. Patients with
progressive disease go off study. The idea behind maintenance therapy is that ofatumumab may
contribute to tumor control early after allogeneic stem cell transplantation while T-cell
based graft-versus leukemia effects are still not fully established. External tumor control
could lower the pressure to taper immunosuppressive drugs early after transplantation and
could thereby indirectly contribute to better GVHD-prophylaxis. Furthermore, anti-CD20
antibodies have proven activity in the treatment of chronic GVHD. In summary, the concept of
a consequent CD20 blockade in the context of allogeneic transplantation could result in
better leukemic control and better GVHD prophylaxis, which is a highly attractive goal.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate after induction therapy
efficacy analysis of anti-CD20 blockade with ofatumumab
week 9
Yes
Johannes Schetelig, PD Dr. med.
Principal Investigator
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
Germany: Paul-Ehrlich-Institut
TUD-CLL-X4-054
NCT01809847
March 2013
December 2016
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