MedTrace Logo

Effect of 2nd Gen TKI in CML

NCT02222272 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 432

Last updated 2024-02-20

No results posted yet for this study

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Michael Schleuning, MD · Zentrum für Knochenmark und Blutstammzelltransplantation

  • Eduardo Olavarria, MD · Hospital de Navarra, Servicio de Hematologia, Pamplona, Spain

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-01
Primary Completion
2014-03-19
Completion
2017-09-29

Countries

  • Denmark
  • Finland
  • Germany
  • Hungary
  • Israel
  • Poland
  • Russia
  • Saudi Arabia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02222272 on ClinicalTrials.gov