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

Contact:

NCT Number:

Protocol:

AAAS7291

Study Status:

Active/Enrolling

Population:

Pediatrics/Adult

Phase:

II

This is a pilot study in pediatric and young adult patients with chronic phase CML (CML-CP) who are currently being treated with a tyrosine kinase inhibitor (TKI). Treatment with a TKI is currently life long. Pediatric patients with CML have long life spans, therefore they will be taking a TKI for a long time, especially during periods of growth and development, and therefore are believed to be at a significantly increased risk for side effects. Patients in this study will stop taking TKI medication and be closely monitored for 3 years to see if they remain cancer free. If their CML returns, we want to find out if those who restart a TKI will again become cancer free.

Are you Eligible? (Inclusion Criteria)

  • Patient must have been diagnosed with CML-CP at < 18 years of age and be < 25 years of age at enrollment.
  • Patient must have histologic verification of CML-CP at original diagnosis.
  • Patient must have no evidence of disease based on a specific test for CML (RQ- PCR) for ≥ 2 consecutive years at the time of enrollment.
  • Patient must also meet all eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Chronic Myeloid Leukemia, Childhood and Adolescent Cancers (Pediatric)

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032