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
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032