MedTrace Logo

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

NCT01392079 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-10-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alemtuzumab

Alemtuzumab 30 mg s.c. 3 × weekly for 28 days (Days 1, 3, 5; 8, 10, 12; etc.)

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER

  • WiSP Wissenschaftlicher Service Pharma GmbH

    collaborator OTHER

  • German CLL Study Group

    collaborator OTHER

  • University of Ulm

    lead OTHER

Principal Investigators

  • Stephan Stilgenbauer, Prof Dr med · University of Ulm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-01-31
Completion
2016-03-31

Countries

  • Austria
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01392079 on ClinicalTrials.gov