Effect of 2nd Gen TKI in CML

NCT02222272 | Completed

• 1 other identifier: EBMT-42201038
• Study Type: observational
• Target: 432
• Locations: 9 countries
• Sites: 10

Brief Summary

Stem cell transplantation will continue to be a treatment option for patients with chronic myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the time of allogeneic stem cell transplantation. While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact on the outcome of allogeneic stem cell transplantation little is known on the impact of prior use of second generation TK inhibitors. Therefore this non interventional prospective study addresses this question and patients undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will be followed by the data office office on engraftment, treatment related mortality, relapse rate and survival, prospectively. Details on TKI therapy will be collected by the participating centers, retrospectively. This is a non interventional prospective study. There is no upper limit to the number of patients entered, but it is estimated that up to 450 patients will be included in 150 centres for this non interventional prospective study. The registry will include patients for three years plus one more year for follow up and data analysis which should then be followed-up until the projected end of the non interventional prospective study.

Conditions

Myeloid Leukemia, Chronic

Keywords

cml; chronic myeloid leukemia; dasatinib; nilotinib; tki; second generation tki; 2nd generation tki

Outcome Measures

Primary Outcomes (1)

• non-relapse mortality (NRM) (treatment related mortality)

  1 year after HSCT

Secondary Outcomes (4)

• treatment related toxic effects

  2 year after HSCT

• overall survival

  2 years after HSCT

• Event Free Survival

  2 years after HSCT

• Relapse Rate

  2 years after HSCT

Other Outcomes (1)

• outcome analyzed by response status to 2nd gen TKI prior to SCT

  2 year after HSCT

Eligibility Criteria

• Age: 18 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:

• All adult patients with chronic myeloid leukaemia in any phase (chronic, accelerated or blastic) who undergo allogeneic stem cell transplantation between 01/01/2010 and 30/09/2013 and have been previously treated with Nilotinib or Dasatinib, regardless of their response to these drugs.

Sponsors & Collaborators

• European Society for Blood and Marrow Transplantation: lead
• Novartis: collaborator

Study Sites (10)

Rigshospitalet

Copenhagen, Denmark

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

University of Freiburg

Freiburg im Breisgau, Germany

Location

University of Muenster

Münster, Germany

Location

St Ivan & St Laszlo Hospital

Budapest, Hungary

Location

Chaim Sheba Medical Centre

Tel Litwinsky, Israel

Location

Medical University of Silesia

Katowice, Poland

Location

St Petersburg State Medical Pavlov University

Saint Petersburg, Russia

Location

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Location

Hammersmith

London, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Schleuning, MD

  Zentrum für Knochenmark und Blutstammzelltransplantation

  PRINCIPAL INVESTIGATOR

• Eduardo Olavarria, MD

  Hospital de Navarra, Servicio de Hematologia, Pamplona, Spain

  STUDY CHAIR

• 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 19, 2014
• First Posted: August 21, 2014
• Study Start: January 1, 2010
• Primary Completion: March 19, 2014
• Study Completion: September 29, 2017
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

HU (1); GB (1); RU (1); SA (1); DK (1); FI (1); DE (2); IL (1); PL (1)