Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2015

Conditions
Chronic Lymphatic Leukemia
Interventions
DRUG

Ofatumumab

"Study treatment comprises eight weeks of induction therapy with ofatumumab in combination with high-dose dexamethasone. The first dose of ofatumumab is 300 mg followed by seven infusions of 2000 mg ofatumumab. Dexamethasone will be given orally at doses of 40 mg on days 1-4 in weeks 1, 3, 5, and 7. Patients who achieved a CR, PR shall proceed to maintenance therapy. Maintenance therapy consists of 6 monthly infusions of 1000 mg ofatumumab.~An HLA-matched sibling donor or HLA-matched unrelated donor can be identified for approximately 70% of patients. Donor search will be completed within six weeks for 95% of the patients. Patients with a donor will proceed to allogeneic HCT as soon as possible prior to, or during maintenance therapy."

Trial Locations (11)

15236

Klinikum Frankfurt (Oder) GmbH, Frankfurt (Oder)

37075

Universitätsmedizin Göttingen, Göttingen

40225

Universitätsklinikum Düsseldorf, Düsseldorf

50937

Klinikum der Universität zu Köln, Cologne

55131

Klinikum der Johannes Gutenberg Universität, Mainz

65191

Deutsche Klinik für Diagnostik, Wiesbaden

69120

Universitätsklinikum Heidelberg, Heidelberg

80804

Städtisches Klinikum München Schwabing, München

89081

Universitätsklinikum Ulm, Ulm

09113

Klinikum Chemnitz GmbH, Chemnitz

01307

Universitätsklinikum Dresden, Dresden

All Listed Sponsors
collaborator

University Hospital Dresden

OTHER

collaborator

University Hospital Ulm

OTHER

collaborator

University Hospital Schleswig-Holstein

OTHER

collaborator

University Hospital of Cologne

OTHER

lead

Technische Universität Dresden

OTHER

NCT01809847 - Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation | Biotech Hunter | Biotech Hunter