Pre-existing Kinase Domain Mutations in Ph-positive Leukemias
Identification of Pre-existing Kinase Domain Mutations in Subclones of Ph-positive Leukemias
1 other identifier
observational
30
1 country
1
Brief Summary
The main task of this study includes analyses of the BCR-ABL1 (breakpoint cluster region/Abelson) gene and mutations in the BCR-ABL1 tyrosine kinase domain within flow-sorted stem cells from the bone marrow and/or peripheral blood specimens. To assess the germline configuration of the patient, DNA from fingernail clippings will be investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 31, 2015
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedOctober 31, 2022
October 1, 2022
6.1 years
October 30, 2015
October 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Leukemic stem/progenitor cells defined by a specific marker profile will be isolated from BM/PB by flow sorting. Screening for and monitoring of BCR-ABL1 TKD mutant subclones at the cDNA/DNA levels within the 1st year of TKI therapy will be done by NGS.
3 years
Eligibility Criteria
The study plan includes 30 adult patients with Ph-positive leukemia.
You may qualify if:
- Established diagnosis of Ph-positive leukemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Anna Kinderkrebsforschunglead
- Medical University of Viennacollaborator
- National Research Center for Radiation Medicine in Kievcollaborator
- St. Petersburg State Pavlov Medical Universitycollaborator
- UHKT Praguecollaborator
Study Sites (1)
Medical Universitiy of Vienna
Vienna, 1090, Austria
Related Publications (3)
Preuner S, Danzer M, Proll J, Potschger U, Lawitschka A, Gabriel C, Lion T. High-quality DNA from fingernails for genetic analysis. J Mol Diagn. 2014 Jul;16(4):459-66. doi: 10.1016/j.jmoldx.2014.02.004. Epub 2014 Apr 30.
PMID: 24795088BACKGROUNDPreuner S, Mitterbauer G, Mannhalter C, Herndlhofer S, Sperr WR, Valent P, Lion T. Quantitative monitoring of BCR/ABL1 mutants for surveillance of subclone-evolution, -expansion, and -depletion in chronic myeloid leukaemia. Eur J Cancer. 2012 Jan;48(2):233-6. doi: 10.1016/j.ejca.2011.08.015. Epub 2011 Sep 28.
PMID: 21955823BACKGROUNDPreuner S, Denk D, Frommlet F, Nesslboeck M, Lion T. Quantitative monitoring of cell clones carrying point mutations in the BCR-ABL tyrosine kinase domain by ligation-dependent polymerase chain reaction (LD-PCR). Leukemia. 2008 Oct;22(10):1956-61. doi: 10.1038/leu.2008.97. Epub 2008 Apr 24. No abstract available.
PMID: 18432261BACKGROUND
Biospecimen
DNA samples from CML patients obtained from bone marrow/peripheral blood and fingernail clippings
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Lion, MD PhD Prof
Children´s Cancer Research Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
October 30, 2015
First Posted
December 31, 2015
Study Start
December 1, 2016
Primary Completion
January 1, 2023
Study Completion
May 1, 2023
Last Updated
October 31, 2022
Record last verified: 2022-10