Clinical trial · Observational
Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I
Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
NCT02981784CI-TRIAL-00024994completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic stem cell transplantation | Procedure | — | UNRESOLVED |
| Ponatinib (Iclusig®) | Drug | Ponatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Ponatinib (PACE trial)
- description
- PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440
- interventionNames
- Drug: Ponatinib (Iclusig®)
- label
- Allogenis stem cell transplantation (EBMT registry)
- description
- EBMT : European Group for Blood and Marrow Transplantation
- interventionNames
- Procedure: allogeneic stem cell transplantation
Primary outcomes (1)
- measure
- Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
- timeFrame
- From date of inclusion until the date of death, assessed up to 180 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CML any phase with T315I mutation * Ph+ ALL with a T315I mutation * Being treated in the PACE trial according to the criteria of this phase II trial * Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen. Exclusion Criteria: * Ph negative patients * Patients under 18 years
References
Publications (0)
Data not yet available
No reference posted for this study.