Myeloproliferative Neoplasms Clinical Trial
Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia
Summary
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.
Full Description
PRIMARY OBJECTIVES:
I. 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).
II. 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.
SECONDARY OBJECTIVE:
I. To describe clinical factors and laboratory correlates affecting the persistence of major molecular remission (MMR) and re-initiation of treatment after stopping TKI (e.g. patient demographics, duration and level of prior molecular remission, duration and type of TKI, clinical presentation at diagnosis and immune studies).
EXPLORATORY OBJECTIVES:
I. To describe change in height standard deviation score over time in patients who are able to discontinue their TKI.
II. To describe the long-term health outcomes including but not limited to gonadal function, endocrine function, and bone metabolism in patients who are able to discontinue TKI as well as those that need to restart TKIs.
III. To describe differences in patient-reported health status after stopping TKIs, including those who need to resume TKI after stopping.
IV. To describe the incidence and characteristics of TKI withdrawal syndrome in children.
V. To evaluate changes in neurocognitive outcomes of patients enrolled on this study using a patient-completed, performance-based, computerized measure of neuropsychological functioning and a parent-report/self-report questionnaire.
OUTLINE:
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.
Eligibility Criteria
Inclusion Criteria:
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
Please note: The lab evaluating disease status and molecular response for this study must be College of American Pathology (CAP) and/or Clinical Laboratory Improvement Amendments (CLIA) certified (United States [US] only), sites in other countries must be certified by their accredited authorities. All labs must use the International Scale guidelines with a sensitivity of detection assay =< 0.01% BCR-ABL1 and be able to report results in =< 2 weeks
Patient must have received any TKI for a minimum of 3 consecutive years at time of enrollment
Patient agrees to discontinue TKI therapy
REGULATORY REQUIREMENTS
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
ELIGIBILITY FOR PATIENT-REPORTED OUTCOMES (PROs):
Age >= 8 years at the time of enrollment
Ability to understand English or Spanish
Cognitive ability to complete instruments according to the primary team
ELIGIBILITY FOR AAML18P1 NEUROCOGNITIVE STUDY:
Patient must be 5 years or older at the time of enrollment
English-, French- or Spanish-speaking
No known history of neurodevelopmental disorder prior to diagnosis of CML (e.g., Down syndrome, Fragile X, William syndrome, mental retardation)
No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
Exclusion Criteria:
Known T3151 mutation
Additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive (+) 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
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There are 170 Locations for this study
Birmingham Alabama, 35233, United States More Info
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Mobile Alabama, 36604, United States More Info
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Mesa Arizona, 85202, United States More Info
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Tucson Arizona, 85719, United States More Info
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Little Rock Arkansas, 72202, United States More Info
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Downey California, 90242, United States More Info
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Long Beach California, 90806, United States More Info
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Los Angeles California, 90027, United States More Info
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Los Angeles California, 90048, United States More Info
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Los Angeles California, 90095, United States More Info
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Madera California, 93636, United States More Info
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Oakland California, 94609, United States More Info
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Oakland California, 94611, United States More Info
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Orange California, 92868, United States More Info
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Palo Alto California, 94304, United States More Info
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Sacramento California, 95817, United States More Info
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San Diego California, 92123, United States More Info
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Aurora Colorado, 80045, United States More Info
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Denver Colorado, 80218, United States More Info
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Hartford Connecticut, 06106, United States More Info
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Wilmington Delaware, 19803, United States More Info
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Washington District of Columbia, 20007, United States
Washington District of Columbia, 20010, United States More Info
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Fort Myers Florida, 33908, United States More Info
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Gainesville Florida, 32610, United States More Info
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Hollywood Florida, 33021, United States More Info
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Jacksonville Florida, 32207, United States More Info
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Miami Florida, 33136, United States More Info
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Miami Florida, 33155, United States More Info
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Orlando Florida, 32806, United States More Info
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Orlando Florida, 32827, United States More Info
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Pensacola Florida, 32504, United States More Info
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Tampa Florida, 33606, United States More Info
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Tampa Florida, 33607, United States More Info
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West Palm Beach Florida, 33407, United States More Info
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Atlanta Georgia, 30322, United States More Info
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Savannah Georgia, 31404, United States More Info
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Honolulu Hawaii, 96826, United States More Info
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Boise Idaho, 83712, United States More Info
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Chicago Illinois, 60611, United States More Info
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Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States More Info
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Maywood Illinois, 60153, United States More Info
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Oak Lawn Illinois, 60453, United States More Info
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Park Ridge Illinois, 60068, United States More Info
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Peoria Illinois, 61637, United States More Info
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Springfield Illinois, 62702, United States More Info
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Winfield Illinois, 60190, United States More Info
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Indianapolis Indiana, 46202, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Iowa City Iowa, 52242, United States More Info
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Lexington Kentucky, 40536, United States More Info
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Louisville Kentucky, 40202, United States More Info
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New Orleans Louisiana, 70118, United States More Info
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New Orleans Louisiana, 70121, United States More Info
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Bangor Maine, 04401, United States More Info
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Scarborough Maine, 04074, United States More Info
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Baltimore Maryland, 21215, United States More Info
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Baltimore Maryland, 21287, United States More Info
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Bethesda Maryland, 20889, United States More Info
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Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States More Info
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Worcester Massachusetts, 01655, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
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Detroit Michigan, 48201, United States More Info
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Detroit Michigan, 48201, United States
East Lansing Michigan, 48824, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
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Kalamazoo Michigan, 49007, United States More Info
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Royal Oak Michigan, 48073, United States More Info
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Minneapolis Minnesota, 55404, United States More Info
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Minneapolis Minnesota, 55455, United States More Info
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Jackson Mississippi, 39216, United States More Info
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Columbia Missouri, 65201, United States More Info
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Kansas City Missouri, 64108, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63141, United States More Info
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Omaha Nebraska, 68114, United States More Info
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Omaha Nebraska, 68198, United States More Info
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Las Vegas Nevada, 89102, United States More Info
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Las Vegas Nevada, 89109, United States More Info
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Las Vegas Nevada, 89135, United States More Info
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Las Vegas Nevada, 89144, United States More Info
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Reno Nevada, 89502, United States More Info
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Hackensack New Jersey, 07601, United States More Info
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Morristown New Jersey, 07960, United States More Info
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New Brunswick New Jersey, 08903, United States More Info
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Paterson New Jersey, 07503, United States More Info
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Albany New York, 12208, United States More Info
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Bronx New York, 10467, United States More Info
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Buffalo New York, 14263, United States More Info
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Mineola New York, 11501, United States
New Hyde Park New York, 11040, United States More Info
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New York New York, 10032, United States More Info
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New York New York, 10065, United States More Info
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New York New York, 10065, United States More Info
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Rochester New York, 14642, United States
Stony Brook New York, 11794, United States More Info
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Syracuse New York, 13210, United States More Info
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Valhalla New York, 10595, United States
Asheville North Carolina, 28801, United States More Info
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Chapel Hill North Carolina, 27599, United States More Info
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Charlotte North Carolina, 28203, United States More Info
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Charlotte North Carolina, 28204, United States More Info
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Greenville North Carolina, 27834, United States More Info
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Winston-Salem North Carolina, 27157, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Akron Ohio, 44308, United States More Info
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Cincinnati Ohio, 45229, United States More Info
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Cleveland Ohio, 44106, United States More Info
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Cleveland Ohio, 44195, United States More Info
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Columbus Ohio, 43205, United States More Info
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Dayton Ohio, 45404, United States More Info
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Toledo Ohio, 43606, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Portland Oregon, 97227, United States More Info
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Portland Oregon, 97239, United States More Info
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Allentown Pennsylvania, 18103, United States More Info
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Danville Pennsylvania, 17822, United States More Info
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Hershey Pennsylvania, 17033, United States More Info
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Philadelphia Pennsylvania, 19104, United States More Info
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Philadelphia Pennsylvania, 19134, United States More Info
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Pittsburgh Pennsylvania, 15224, United States More Info
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Providence Rhode Island, 02903, United States More Info
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Columbia South Carolina, 29203, United States More Info
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Greenville South Carolina, 29605, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Chattanooga Tennessee, 37403, United States More Info
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Knoxville Tennessee, 37916, United States More Info
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Memphis Tennessee, 38105, United States More Info
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Nashville Tennessee, 37203, United States More Info
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Nashville Tennessee, 37232, United States More Info
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Amarillo Texas, 79106, United States More Info
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Austin Texas, 78723, United States More Info
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Corpus Christi Texas, 78411, United States More Info
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Dallas Texas, 75230, United States More Info
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Dallas Texas, 75390, United States More Info
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El Paso Texas, 79905, United States More Info
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Houston Texas, 77030, United States More Info
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Houston Texas, 77030, United States More Info
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Lubbock Texas, 79410, United States More Info
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Lubbock Texas, 79415, United States More Info
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San Antonio Texas, 78207, United States More Info
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San Antonio Texas, 78229, United States More Info
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San Antonio Texas, 78229, United States More Info
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Salt Lake City Utah, 84113, United States More Info
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Charlottesville Virginia, 22908, United States More Info
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Falls Church Virginia, 22042, United States More Info
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Norfolk Virginia, 23507, United States More Info
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Richmond Virginia, 23298, United States More Info
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Roanoke Virginia, 24014, United States More Info
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Seattle Washington, 98105, United States More Info
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Spokane Washington, 99204, United States More Info
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Tacoma Washington, 98405, United States More Info
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Tacoma Washington, 98431, United States More Info
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Charleston West Virginia, 25304, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Marshfield Wisconsin, 54449, United States More Info
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Hunter Regional Mail Centre New South Wales, 2310, Australia More Info
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Westmead New South Wales, 2145, Australia
Clayton Victoria, 3168, Australia More Info
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Parkville Victoria, 3052, Australia More Info
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Perth Western Australia, 6009, Australia More Info
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Edmonton Alberta, T6G 2, Canada More Info
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Winnipeg Manitoba, R3E 0, Canada More Info
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Hamilton Ontario, L8N 3, Canada More Info
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Ottawa Ontario, K1H 8, Canada More Info
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Toronto Ontario, M5G 1, Canada More Info
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Montreal Quebec, H3H 1, Canada More Info
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Montreal Quebec, H3T 1, Canada More Info
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Quebec , G1V 4, Canada More Info
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Caguas , 00726, Puerto Rico More Info
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