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RecruitingLast updated: 5 February 2024

This phase II trial is evaluating whether stopping targeted therapy (tyrosine kinase inhibitors) affects treatment-free remission in people with chronic phase myeloid leukaemiaStopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Clinical summary

Summary

Tyrosine kinase inhibitors (TKIs) are a type of medication that help keep the level of disease low (called molecular remission). However, after being in molecular remission for a specific amount of time, it may not be necessary to take TKIs. This trial is investigating whether stopping TKIs will help patients with chronic myeloid leukaemia in chronic phase continue or re-achieve molecular remission. Participants in this trial will stop taking tyrosine kinase inhibitor (TKI) medication within 10 days of trial enrolment. Participants will then undergo peripheral blood collection to monitor loss of major molecular remission (MMR) every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Participants who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.

Conditions

This trial is treating patients with chronic myeloid leukaemia.

Cancer

Blood Cancers Haematological

Age

People>25

Phase

II

More information

Trial Identifiers

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Trial sponsor

National Cancer Institute (NCI), Children's Oncology Group

Scientific Title

Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Eligibility

Inclusion

  • Patient must have been diagnosed with CML-CP at < 18 years of age.
  • Patient must have histologic verification of CML-CP at original diagnosis
  • Patient must be in molecular remission (MR) with a BCR-ABL1 level of =< 0.01% BCR-ABL1 as measured using the International Scale (IS) by RQ-PCR for >= 2 consecutive years at the time of enrollment

    • Please note: The lab evaluating disease status and molecular response for this study must be College of American Pathology (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US] only), sites in other countries must be certified by their accredited authorities. All labs must use the International Scale guidelines with a sensitivity of detection assay =< 0.01% BCR-ABL1 and be able to report results in =< 2 weeks
  • Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment
  • Patient agrees to discontinue TKI therapy
  • REGULATORY REQUIREMENTS
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • ELIGIBILITY FOR PATIENT-REPORTED OUTCOMES (PROs):
  • Age >= 8 years at the time of enrollment
  • Ability to understand English or Spanish
  • Cognitive ability to complete instruments according to the primary team
  • ELIGIBILITY FOR AAML18P1 NEUROCOGNITIVE STUDY:
  • Patient must be 5 years or older at the time of enrollment
  • English-, French- or Spanish-speaking
  • No known history of neurodevelopmental disorder prior to diagnosis of CML (e.g., Down syndrome, Fragile X, William syndrome, mental retardation)
  • No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli

Exclusion

  • Known T3151 mutation
  • Additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive (+) cells at any time prior to enrollment that include "major route" abnormalities (second Ph, trisomy 8, isochromosome 17q, trisomy 19), complex karyotype or abnormalities of 3q26.2
  • History of accelerated phase or blast crisis CML
  • Female patients who are pregnant
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained

Inclusion

  • You are currently receiving treatment for your cancer.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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