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)
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Clinical Trial Information
Trial Contact: Parker, Melanie; Spinelli, Jennifer; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321-843-1036 ; 321.841.5357 ; 321-843-5284 ; 3218412008 ; 321-841-7561
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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Treatment: Procedure: Biospecimen Collection; Other: Drug Withdrawn; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Tyrosine Kinase Inhibitor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
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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.
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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
