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Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in 17p- Chronic Lymphocytic Leukemia (CLL)

NCT01675102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2019-08-16

No results posted yet for this study

Summary

17p-/p53-mutated chronic lymphocytic leukemia (CLL) is an orphan disease, accounting for approximately 5% of newly diagnosed CLL. This subgroup of patients has a very poor outcome after chemoimmunotherapy. Allogeneic HCT may change the poor prognosis. In a retrospective EBMT-analysis on 44 patients with advanced 17p-CLL 2-year progression-free survival was 45% (95% CI, 30% to 60%) after allogeneic HCT (Allogeneic hematopoietic stem-cell transplantation for chronic lymphocytic leukemia with 17p deletion: a retrospective European Group for Blood and Marrow Transplantation analysis. J Clin Oncol, 2008, 26, 5094-5100).

Referring to these favorable results and small additional series, patients with 17p-CLL requiring therapy are considered to have an indication for allogeneic transplantation by many CLL study groups. Several CLL study groups recommend allogeneic HCT in 17p-CLL as part of the first- or second line treatment.

The aim is to collect additional evidence on allogeneic HCT in 17p-/p53-mutated CLL in first or second remission by a non-interventional prospective study. Patients shall be registered prior to HCT at the Leiden Office in order to rule out a reporting bias after transplantation.

Conditions

Sponsors & Collaborators

  • European Research Initiative on CLL

    collaborator UNKNOWN

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Johannes Schetelig, MD · Medizinische Klinik und Poliklinik I, University Hospital Dresden, Germany

  • Nicolaus Kroeger, MD · BMT Centre, University Hospital Eppendorf, Hamburg, Germany

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-01
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Denmark
  • Finland
  • Germany
  • Israel
  • Netherlands
  • Sweden
  • United Kingdom

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 NCT01675102 on ClinicalTrials.gov