Help the Future of Cancer Treatment

Volunteering for a clinical trial is a contribution to the future of medicine that only you can make.

AAML18P1, Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Primary Investigator
Sedig, Laura
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT03817398
UM Number
2019.142
Age Group
Both
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
11095
Secondary Protocol No
HUM00168081
Scope
National
Sponsor Type
Institutional
Disease Site
Myeloid and Monocytic Leukemia
Summary
This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Eligibility: Inclusion Criteria
  •   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 Criteria
  •   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