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Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia

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

  • Clinical Trial Information

    Trial Contact: Parker, Melanie; Spinelli, Jennifer; Armatti, Julie M; Doyle, Katherine M

  • IRB No: AAML18P1

    Protocol Abbrev: AAML18P1

    Principal Investigator: Amy A. Smith, MD

    Phase: Drug: Phase II

    Age Group: Adult;Pediatric

    Secondary Protocol No: AAML18P1

    Treatment: Procedure: Biospecimen Collection; Other: Drug Withdrawn; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Tyrosine Kinase Inhibitor

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT03817398

  • Objective

    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). To estimate the re-induction rate and maintenance of molecular remission (BCR-ABL1 =< 0.1%) at 1 year after restarting TKI for children, adolescents, and young adults.

  • Key Eligibility

    Ages Eligible for Study: up to 25 Years (Child, Adult)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No
    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
    Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment
    Patient agrees to discontinue TKI therapy