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

NCT01675102 | Completed

• 1 other identifier: EBMT-42204420
• Study Type: observational
• Target: 41
• Locations: 7 countries
• Sites: 10

Brief 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

CLL

Keywords

del 17p; chronic lymphocytic leukemia; cll; mutation; p53

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate

  1 year after HSCT

Secondary Outcomes (2)

• Rate of MRD-negative complete remissions

  1 year after HSCT

• Overall survival, cumulative incidence of relapse and non-relapse mortality

  1 year after HSCT

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

eligible patients from EBMT centres

You may qualify if:

• p-/p53-mutated CLL by FISH or sequencing, confirmed by review by an experienced laboratory
• first or second partial remission or complete remission at HCT according to the updated NCI-criteria (Hallek 2008)
• MRD diagnostic as part of the local standard follow up
• allogeneic HCT from a matched related or unrelated donor with up to one mismatch refering to HLA-A, -B, -C and DRB1

You may not qualify if:

• ex vivo T-cell depletion
• in vivo T-cell depletion with alemtuzumab

Sponsors & Collaborators

• European Society for Blood and Marrow Transplantation: lead
• European Research Initiative on CLL: collaborator

Study Sites (10)

Rigshospitalitet

Copenhagen, Denmark

Location

University Central Hospital

Helsinki, Finland

Location

Universitaetsklinikum

Dresden, Germany

Location

University Hospital Eppendorf

Hamburg, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

Klinik fuer Innere Medzin III

Ulm, Germany

Location

Chaim Sheba Medical Centre

Tel Litwinsky, Israel

Location

University Hospital

Maastricht, Netherlands

Location

University Hospital

Lund, Sweden

Location

City Hospital

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Chromosome 17 deletion; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johannes Schetelig, MD

  Medizinische Klinik und Poliklinik I, University Hospital Dresden, Germany

  PRINCIPAL INVESTIGATOR

• Nicolaus Kroeger, MD

  BMT Centre, University Hospital Eppendorf, Hamburg, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: December 31, 2015
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

NL (1); FI (1); SE (1); DE (4); GB (1); IL (1); DK (1)