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AAML18P1


Title AAML18P1 - Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)
Therapeutic Area Chronic Myeloid Leukemia
Principal Investigator Jason Law, MD
Min Age 0 Years
Max Age 25 Years
Gender Any
Contact Sarah Sexton
617-636-5558
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03817398

Overview

This phase II trial studies how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the level of disease is very low, it's called molecular remission. TKIs are a type of medication that help keep this level low. However, after being in molecular remission for a specific amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid leukemia in chronic phase continue or re-achieve molecular remission.

Study Details

Inclusion Criteria

  • Patient must have been diagnosed with CML-CP at < 18 years of age.
  •  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

Exclusion Criteria

  • 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

Study Requirements

Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.

After completion of study treatment, patients are followed up annually.