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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02981784




Registration number
NCT02981784
Ethics application status
Date submitted
21/11/2016
Date registered
5/12/2016
Date last updated
5/12/2016

Titles & IDs
Public title
Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I
Scientific title
Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
Secondary ID [1] 0 0
69HCL16_0716
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Ponatinib (Iclusig®)
Treatment: Surgery - allogeneic stem cell transplantation

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

Allogenis stem cell transplantation (EBMT registry) - EBMT : European Group for Blood and Marrow Transplantation


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

Treatment: Surgery: allogeneic stem cell transplantation
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
Timepoint [1] 0 0
From date of inclusion until the date of death, assessed up to 180 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ph negative patients

- Patients under 18 years

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
184
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Pierre-Bénite

Funding & Sponsors
Primary sponsor type
Other
Name
Hospices Civils de Lyon
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02981784
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries