Clinical trial · Observational
Effect of 2nd Gen TKI in CML
Effect of Prior Therapy With Nilotinib or Dasatinib on the Outcome After Allogeneic Stem Cell Transplantation for Patients With Chronic Myeloid Leukaemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloid Leukemia, Chronic | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- non-relapse mortality (NRM) (treatment related mortality)
- timeFrame
- 1 year after HSCT
Secondary outcomes (4)
- measure
- treatment related toxic effects
- timeFrame
- 2 year after HSCT
- measure
- overall survival
- timeFrame
- 2 years after HSCT
- measure
- Event Free Survival
- timeFrame
- 2 years after HSCT
- measure
- Relapse Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria:
References
Publications (0)
Data not yet available