NCT05605379 CML Pediatric ITK Response According to Molecular Identification at Diagnosis
| NCT ID | NCT05605379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Chronic Myeloid Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2023-02-27 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Treatment of chronic myeloid leukemia (CML) has been revolutionized by tyrosine kinase inhibitor (TKI). Nevertheless, case of failure and suboptimal response are still observed even in children. Pediatric CML is a rare disease and differs from adult in terms of disease presentation and treatment response underlying a likely different CML biology. Molecular mechanisms that induce resistance to TKI are still poorly characterized except mutations in the tyrosine kinase domain of BCR::ABL1. We propose to search for a molecular signature to predict the response to TKI in the pediatric population.
Eligibility Criteria
Inclusion Criteria: * Age at diagnosis less than or equal to 18 years * Presence of a Philadelphia chromosome detected by cytogenetic analysis (conventional karyotype or Fluorescence In Situ Hybridization (FISH)) and a BCR ::ABL1 transcript e13a2 ou e14a2 * Diagnosis in chronic phase according to the European Leukemia Net (ELN) criteria * First-line treatment with TKIs * Possible pre-treatment with hydroxyurea * DNA available at diagnosis * RNA available for a sub-group patients (8 responders vs 8 no responders) Exclusion Criteria: * Age at diagnosis more than 18 years * Diagnosis in accelerated phase or blastic phase * First line treatment other than TKI
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05605379 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Chronic Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05605379 currently recruiting?
Yes, NCT05605379 is actively recruiting participants. Contact the research team at stephanie.dulucq@chu-bordeaux.fr for enrollment information.
Where is the NCT05605379 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT05605379 clinical trial?
NCT05605379 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 88 participants.
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