Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I
Completed
- Conditions
- Leukemia
- Interventions
- Drug: Ponatinib (Iclusig®)Procedure: allogeneic stem cell transplantation
- Registration Number
- NCT02981784
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
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.
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Exclusion Criteria
- Ph negative patients
- Patients under 18 years
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ponatinib (PACE trial) Ponatinib (Iclusig®) PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440 Allogenis stem cell transplantation (EBMT registry) allogeneic stem cell transplantation EBMT : European Group for Blood and Marrow Transplantation
- Primary Outcome Measures
Name Time Method Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months) From date of inclusion until the date of death, assessed up to 180 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Hospitalier Lyon-Sud
🇫🇷Pierre-Bénite, France