Status:
ACTIVE_NOT_RECRUITING
Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Eligibility:
All Genders
Up to 25 years
Phase:
PHASE2
Brief 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 l...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the 2-year treatment free remission (TFR) rate of children, adolescents, and young adults with chronic myeloid leukemia - chronic phase (CML-CP) following disconti...
Eligibility Criteria
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
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03817398
Start Date
November 8 2019
End Date
June 30 2026
Last Update
December 22 2025
Active Locations (173)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
3
Banner Children's at Desert
Mesa, Arizona, United States, 85202
4
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719