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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02981784

Enrollment

184

Registered

2016-12-05

Start date

2000-01-31

Completion date

2015-12-31

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

chronic myeloid leukemia (CML), Philadelphia-positive (Ph+), Acute Lymphoblastic Leukemia (ALL)

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).

Interventions

DRUGPonatinib (Iclusig®)

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

PROCEDUREallogeneic stem cell transplantation

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026