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Protocol No. AAML18P1

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

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

Objective
The overall goals of this study are:
  • To determine if children, adolescents, and young adults can stop taking their TKI medication and remain in molecular remission
  • To see if children, adolescents, and young adults who restart TKI will re-achieve molecular remission

  • Treatment
    STOP TKI MEDICATION: Disease evaluation every 4 weeks x 13 (year 1), Then every 6 weeks x 9 (year 2), Then every 12 weeks x 4 (year 3)
    LOSS OF MOLECULAR REMISSION AT ANY TIME: RESTART TKI PCR evaluation every 4 weeks x 13 (year 1),Then every 6 weeks x 9 (year 2), Then every 12 weeks x 4 (year 3)
    CONTINUED MMR: Continue monitoring schedule per standard of care

    Description Phase 2 stopping TKIs to access treatment free remission in CML-CP

    Key Eligibility
  • Must have been diagnosed with CML-CP at less than 18 years of age
  • Must be less than 25 years of age at enrollment
  • Must have histologic verification of CML-CP at original diagnosis
  • Must be in molecular remission with at least a MR4 (less than 0.01% BCR-ABL1 (International Scale [IS]) level by RQ-PCR) for greater than or equal to 2 consecutive years at the time of enrollment
  • Must have received their current TKI for a minimum of 3 consecutive years at time of enrollment
  • Agrees to discontinue TKI therapy
    EXCLUSION
  • Known T3151 mutation
  • Additional clonal chromosomal abnormalities in Ph+ 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

  • Applicable Disease Sites Leukemia

    Status Open

    Participating Institutions UW Hospital and Clinics