AAML18P1. Stopping tyrosine kinase inhibitors (TKI) to assess treatment-free remission (TFR) in pediatric chronic myeloid leukemia - chronic phase (CML-CP)
Categories (click each to see list of all clinical trials associated with that category): CTO Pediatric Trials (ONC), Pediatric (PEDONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Beck, Jill
Eligibility: https://clinicaltrials.gov/study/NCT03817398?term=NCT03817398&rank=1
Summary
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 discontinuation tyrosine kinase inhibitor (TKI).
II. To estimate the re-induction rate and maintenance of major molecular remission (MMR/MR3) at 1 year after restarting TKI for children, adolescents, and young adults.
SECONDARY OBJECTIVES:
I. To describe clinical factors and laboratory correlates affecting the persistence of MMR and re-initiation of treatment after stopping TKI (e.g. patient demographics, duration and level of prior molecular remission, duration and type of TKI, clinical presentation at diagnosis and immune studies).