Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I

Hospices Civils de Lyon184 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

184

Conditions

Leukemia

Interventions

Ponatinib (Iclusig®)DRUG

Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.

allogeneic stem cell transplantationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Outcomes

Primary Outcomes

Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)

Time frame: From date of inclusion until the date of death, assessed up to 180 months

Data from ClinicalTrials.gov

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