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Trial record 16 of 37 for:    ponatinib

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

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ClinicalTrials.gov Identifier: NCT02981784
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Leukemia Drug: Ponatinib (Iclusig®) Procedure: allogeneic stem cell transplantation

Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
Study Start Date : January 2000
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2015


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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981784


Locations
France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02981784     History of Changes
Other Study ID Numbers: 69HCL16_0716
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
chronic myeloid leukemia (CML)
Philadelphia-positive (Ph+)
Acute Lymphoblastic Leukemia (ALL)

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Ponatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action