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

NCT ID: NCT02981784

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Leukemia

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ponatinib (PACE trial)

PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440

Ponatinib (Iclusig®)

Intervention Type DRUG

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

allogeneic stem cell transplantation

Intervention Type PROCEDURE

Interventions

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Ponatinib (Iclusig®)

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

Intervention Type DRUG

allogeneic stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Lyon-Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL16_0716

Identifier Type: -

Identifier Source: org_study_id