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

Leukemia Clinical Trial

Official title:

Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981784
• Other study ID #: 69HCL16_0716
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: December 1, 2016
• Start date: January 2000
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2015
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia

Intervention

Drug:
• Ponatinib (Iclusig®)
Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.

Procedure:
• allogeneic stem cell transplantation

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon-Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No