Last reviewed · How we verify
A Prospective, Multi-center Phase II Study of Subcutaneous Alemtuzumab Combined With Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allogeneic Stem-cell Transplantation, in Chronic Lymphocytic Leukemia Which is Associated With 17p Deletion or is Refractory to Fludarabine
Aims and objectives * Assessment of the efficacy of the study treatment in the study population in terms of response rate, progression-free survival, failure-free survival and overall survival. * Acquisition of further data to expand the data base on the toxicity of the study treatment. * Assessment of the efficacy of the study treatment in biological risk groups. * Assessment of response in terms of minimal residual disease. Number of patients and estimated duration Total no. of patients: 122 (\~29 with 17p deletion for first-line therapy, \~29 with 17p deletion for second- or higher-line treatment, \~65 fludarabine-refractory irrespective of 17p status). Duration for each patient: Max. 12 weeks of treatment in three 4-week cycles, then up to two years maintenance treatment.
Details
| Lead sponsor | University of Ulm |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 135 |
| Start date | 2008-02 |
| Completion | 2016-03 |
Conditions
- Chronic Lymphocytic Leukemia
Interventions
- Alemtuzumab
Primary outcomes
- Response rate — 2.5 years
Time points for response evaluation according to NCI criteria will be: * The end of each treatment cycle: after 12 doses (4 weeks actual treatment), 24 doses (8 weeks actual treatment), and 36 doses (12 weeks actual treatment) of alemtuzumab * During maintenance therapy, every three months * During follow-up, every three months * A final response assessment will be made at the end of study treatment if the patient's participation is ended at a point other than one of those specified above.
Countries
Austria, France, Germany