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Brief Title: Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation
Official Title: Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation(CLL-X4 Trial)
Study ID: NCT01809847
Brief Summary: To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of allogeneic HCT in CLL
Detailed Description: 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.
Minimum Age: 56 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
Universitätsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Städtisches Klinikum München Schwabing, München, Bayern, Germany
Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder), Brandenburg, Germany
Deutsche Klinik für Diagnostik, Wiesbaden, Hessen, Germany
Universitätsmedizin Göttingen, Göttingen, Niedersachsen, Germany
Universitätsklinikum Düsseldorf, Düsseldorf, Nordrhein-Westfalen, Germany
Klinikum der Universität zu Köln, Köln, Nordrhein-Westfalen, Germany
Klinikum der Johannes Gutenberg Universität, Mainz, Rheinland-Pfalz, Germany
Klinikum Chemnitz GmbH, Chemnitz, Sachsen, Germany
Universitätsklinikum Dresden, Dresden, Sachsen, Germany
Name: Johannes Schetelig, PD Dr. med.
Affiliation: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden
Role: PRINCIPAL_INVESTIGATOR