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

December 1, 2016 updated by: Hospices Civils de Lyon

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69310
        • Centre hospitalier Lyon-Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All 128 T315I+ patients from PACE comprised the ponatinib group of this study. Fifty-six patients from the EBMT database comprised the allo-SCT group

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ponatinib (PACE trial)
PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440
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.
Allogenis stem cell transplantation (EBMT registry)
EBMT : European Group for Blood and Marrow Transplantation
Procedure: allogeneic stem cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From date of inclusion until the date of death, assessed up to 180 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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