Subcutaneous Alemtuzumab Combined With Oral Dexamethasone, Followed by Alemtuzumab Maintenance or Allo-SCT in CLL With 17p- or Refractory to Fludarabine

• Status: Completed
• Trial end date: 2016-03-01

Summary

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.

• Phase: Phase 2

Details

• Lead Sponsor: University of Ulm
• Collaborators: German CLL Study Group; IMSE, TU Munich (Biometry); Technische Universität München; WiSP Wissenschaftlicher Service Pharma GmbH
• Treatments: Alemtuzumab; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fludarabine; Fludarabine phosphate; Vidarabine