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

Who is this study for? Patients with Chronic Myelogenous Leukemia
What treatments are being studied? Biospecimen Collection+Drug Withdrawn+Quality-of-Life Assessment+Questionnaire Administration+Tyrosine Kinase Inhibitor
Status: Recruiting
Location: See all (170) locations...
Intervention Type: Other, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: No
View:

• 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

Locations
United States
Alabama
Children's Hospital of Alabama
Recruiting
Birmingham
USA Health Strada Patient Care Center
Recruiting
Mobile
Arkansas
Arkansas Children's Hospital
Recruiting
Little Rock
Arizona
Banner Children's at Desert
Recruiting
Mesa
Banner University Medical Center - Tucson
Recruiting
Tucson
California
Kaiser Permanente Downey Medical Center
Recruiting
Downey
Miller Children's and Women's Hospital Long Beach
Recruiting
Long Beach
Children's Hospital Los Angeles
Recruiting
Los Angeles
Mattel Children's Hospital UCLA
Recruiting
Los Angeles
Valley Children's Hospital
Recruiting
Madera
Kaiser Permanente-Oakland
Recruiting
Oakland
UCSF Benioff Children's Hospital Oakland
Recruiting
Oakland
Children's Hospital of Orange County
Recruiting
Orange
Lucile Packard Children's Hospital Stanford University
Recruiting
Palo Alto
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento
Rady Children's Hospital - San Diego
Not yet recruiting
San Diego
Colorado
Children's Hospital Colorado
Recruiting
Aurora
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Recruiting
Denver
Connecticut
Connecticut Children's Medical Center
Recruiting
Hartford
Washington, D.c.
Children's National Medical Center
Recruiting
Washington
MedStar Georgetown University Hospital
Recruiting
Washington
Delaware
Alfred I duPont Hospital for Children
Recruiting
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
Recruiting
Fort Myers
University of Florida Health Science Center - Gainesville
Recruiting
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Recruiting
Hollywood
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville
Nicklaus Children's Hospital
Recruiting
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami
Arnold Palmer Hospital for Children
Recruiting
Orlando
Nemours Children's Hospital
Recruiting
Orlando
Sacred Heart Hospital
Recruiting
Pensacola
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa
Tampa General Hospital
Recruiting
Tampa
Saint Mary's Hospital
Recruiting
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
Recruiting
Atlanta
Memorial Health University Medical Center
Recruiting
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu
Iowa
Blank Children's Hospital
Recruiting
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Recruiting
Iowa City
Idaho
Saint Luke's Cancer Institute - Boise
Recruiting
Boise
Illinois
Lurie Children's Hospital-Chicago
Recruiting
Chicago
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago
University of Illinois
Recruiting
Chicago
Loyola University Medical Center
Recruiting
Maywood
Advocate Children's Hospital-Oak Lawn
Recruiting
Oak Lawn
Advocate Children's Hospital-Park Ridge
Recruiting
Park Ridge
Saint Jude Midwest Affiliate
Recruiting
Peoria
Southern Illinois University School of Medicine
Recruiting
Springfield
Indiana
Riley Hospital for Children
Recruiting
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Recruiting
Lexington
Norton Children's Hospital
Recruiting
Louisville
Louisiana
Children's Hospital New Orleans
Recruiting
New Orleans
Ochsner Medical Center Jefferson
Recruiting
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Recruiting
Boston
Tufts Children's Hospital
Active, not recruiting
Boston
UMass Memorial Medical Center - University Campus
Recruiting
Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore
Sinai Hospital of Baltimore
Recruiting
Baltimore
Walter Reed National Military Medical Center
Recruiting
Bethesda
Maine
Eastern Maine Medical Center
Recruiting
Bangor
Maine Children's Cancer Program
Recruiting
Scarborough
Michigan
C S Mott Children's Hospital
Recruiting
Ann Arbor
Children's Hospital of Michigan
Recruiting
Detroit
Wayne State University/Karmanos Cancer Institute
Recruiting
Detroit
Michigan State University Clinical Center
Recruiting
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Recruiting
Grand Rapids
Bronson Methodist Hospital
Recruiting
Kalamazoo
Beaumont Children's Hospital-Royal Oak
Recruiting
Royal Oak
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Recruiting
Minneapolis
Missouri
Columbia Regional
Recruiting
Columbia
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City
Mercy Hospital Saint Louis
Recruiting
Saint Louis
Washington University School of Medicine
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
Mission Hospital
Recruiting
Asheville
UNC Lineberger Comprehensive Cancer Center
Recruiting
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte
Novant Health Presbyterian Medical Center
Recruiting
Charlotte
East Carolina University
Recruiting
Greenville
Wake Forest University Health Sciences
Recruiting
Winston-salem
North Dakota
Sanford Broadway Medical Center
Recruiting
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
Recruiting
Omaha
University of Nebraska Medical Center
Recruiting
Omaha
New Jersey
Hackensack University Medical Center
Recruiting
Hackensack
Morristown Medical Center
Recruiting
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Recruiting
New Brunswick
Saint Joseph's Regional Medical Center
Recruiting
Paterson
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas
Summerlin Hospital Medical Center
Recruiting
Las Vegas
Sunrise Hospital and Medical Center
Recruiting
Las Vegas
University Medical Center of Southern Nevada
Recruiting
Las Vegas
Renown Regional Medical Center
Recruiting
Reno
New York
Albany Medical Center
Recruiting
Albany
Montefiore Medical Center - Moses Campus
Recruiting
Bronx
Roswell Park Cancer Institute
Recruiting
Buffalo
NYU Winthrop Hospital
Recruiting
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park
Memorial Sloan Kettering Cancer Center
Recruiting
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Recruiting
New York
NYP/Weill Cornell Medical Center
Recruiting
New York
University of Rochester
Active, not recruiting
Rochester
Stony Brook University Medical Center
Recruiting
Stony Brook
State University of New York Upstate Medical University
Recruiting
Syracuse
New York Medical College
Recruiting
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Recruiting
Akron
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland
Nationwide Children's Hospital
Recruiting
Columbus
Dayton Children's Hospital
Recruiting
Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
Recruiting
Portland
Oregon Health and Science University
Recruiting
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown
Geisinger Medical Center
Recruiting
Danville
Penn State Children's Hospital
Recruiting
Hershey
Children's Hospital of Philadelphia
Recruiting
Philadelphia
Saint Christopher's Hospital for Children
Recruiting
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh
Rhode Island
Rhode Island Hospital
Recruiting
Providence
South Carolina
Prisma Health Richland Hospital
Recruiting
Columbia
BI-LO Charities Children's Cancer Center
Recruiting
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls
Tennessee
T C Thompson Children's Hospital
Suspended
Chattanooga
East Tennessee Childrens Hospital
Suspended
Knoxville
Saint Jude Children's Research Hospital
Recruiting
Memphis
The Children's Hospital at TriStar Centennial
Recruiting
Nashville
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville
Texas
Texas Tech University Health Sciences Center-Amarillo
Recruiting
Amarillo
Dell Children's Medical Center of Central Texas
Recruiting
Austin
Driscoll Children's Hospital
Recruiting
Corpus Christi
Medical City Dallas Hospital
Recruiting
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas
El Paso Children's Hospital
Recruiting
El Paso
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston
M D Anderson Cancer Center
Recruiting
Houston
Covenant Children's Hospital
Recruiting
Lubbock
UMC Cancer Center / UMC Health System
Recruiting
Lubbock
Children's Hospital of San Antonio
Recruiting
San Antonio
Methodist Children's Hospital of South Texas
Recruiting
San Antonio
University of Texas Health Science Center at San Antonio
Recruiting
San Antonio
Utah
Primary Children's Hospital
Recruiting
Salt Lake City
Virginia
Inova Fairfax Hospital
Recruiting
Falls Church
Children's Hospital of The King's Daughters
Recruiting
Norfolk
Virginia Commonwealth University/Massey Cancer Center
Recruiting
Richmond
Carilion Children's
Recruiting
Roanoke
Washington
Seattle Children's Hospital
Recruiting
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane
Madigan Army Medical Center
Recruiting
Tacoma
Mary Bridge Children's Hospital and Health Center
Recruiting
Tacoma
Wisconsin
University of Wisconsin Carbone Cancer Center
Recruiting
Madison
Marshfield Medical Center-Marshfield
Recruiting
Marshfield
West Virginia
West Virginia University Charleston Division
Recruiting
Charleston
Other Locations
Australia
Monash Medical Center-Clayton Campus
Recruiting
Clayton
John Hunter Children's Hospital
Recruiting
Hunter Regional Mail Centre
Royal Children's Hospital
Recruiting
Parkville
Perth Children's Hospital
Recruiting
Perth
The Children's Hospital at Westmead
Recruiting
Westmead
Canada
University of Alberta Hospital
Recruiting
Edmonton
IWK Health Centre
Recruiting
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Recruiting
Hamilton
Children's Hospital
Recruiting
London
Centre Hospitalier Universitaire Sainte-Justine
Recruiting
Montreal
The Montreal Children's Hospital of the MUHC
Recruiting
Montreal
Children's Hospital of Eastern Ontario
Recruiting
Ottawa
Centre Hospitalier Universitaire de Quebec
Recruiting
Quebec
Hospital for Sick Children
Recruiting
Toronto
CancerCare Manitoba
Recruiting
Winnipeg
Puerto Rico
HIMA San Pablo Oncologic Hospital
Recruiting
Caguas
Time Frame
Start Date: July 15, 2019
Estimated Completion Date: June 30, 2026
Participants
Target number of participants: 110
Treatments
Experimental: Basic Science (stop taking TKI, biospecimen collection)
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.
Authors
Craig Erker, Angela R. Girvin, Hamayun Imran, Elyssa M. Rubin, Robin Y. Dulman, Nina S. Kadan-Lottick, Alissa Kahn, Eric C. Larsen, Kathryn L. Laurie, Marcio H. Malogolowkin, Jessica C. Hochberg, Douglas S. Hawkins, Mary L. Schmidt, Julio C. Barredo, Gita V. Massey, Matthew A. Kutny, Jeffrey W. Taub, Eric J. Lowe, William A. May, Sonali Chaudhury, Nadine P. SantaCruz, Jenna Rossoff, Ashok B. Raj, Keith J. August, Chana L. Glasser, Kishor M. Bhende, Lisa Gennarini, Stanton C. Goldman, Thomas W. McLean, Michael S. Isakoff, Justine M. Kahn, Kayelyn J. Wagner, Ziad A. Khatib, Mukund G. Dole, David L. Becton, Laura E. Agresta, Phillip E. Barnette, Benjamin E. Mizukawa, Rabi Hanna, Timothy C. Griffin, Robin D. Hanson, Vonda L. Crouse, Juan F. Rico, Erwood G. Edwards, Ranjan Bista, Jennifer A. Domm, Don E. Eslin, William B. Slayton, Lolie C. Yu, Iftikhar Hanif, Holly E. Pariury, Mark A. Ranalli, David S. Dickens, Erin K. Barr, Leo Mascarenhas, Erin Wright, Ray C. Pais, Laura E. Hogan, Jamie L. Dargart, Theodore B. Moore, Jason Law, Duncan S. Stearns, Andrew L. Pendleton, Barbara A. Gruner, Sureyya Savasan, Craig A. Mullen, Jose M. Esquilin, Rajen Mody, Aarati V. Rao, Joseph C. Torkildson, Michelle A. Manalang, Clare J. Twist, Craig Lotterman, Erlyn C. Smith, Aniket Saha, Burton E. Appel, Eugenia Chang, Sandeep Batra, Arlene S. Redner, Alexander J. Chou, Meghann P. McManus, Richard A. Drachtman, James T. Badgett, Robert G. Irwin, Carla B. Golden, Mallorie B. Heneghan, Douglas J. Scothorn, Eugene Suh, Judy L. Felgenhauer, Jacob A. Troutman, Minnie Abromowitch, Kelly W. Maloney, Wade T. Kyono, Amy A. Smith, William D. Roberts, Daniel J. Bergsagel, Gregory P. Brandt, Alan D. Friedman, Scott M. Bradfield, Lisa M. McGregor, Robert M. Cooper, Laura A. Campbell, Michele S. Redell, Jennifer J. Welch, Jagadeesh Ramdas, Philip M. Monteleone, Stuart L. Cramer, Andrea R. Whitfield, Jay Michael S. Balagtas, Joel A. Kaplan, Jean M. Tersak, Gregory E. Halligan, Robert J. Hayashi, Tamra L. Slone, Samuel J. Milanovich, Alan K. Ikeda, Samantha L. Mallory, Enrique A. Escalon, Nkechi I. Mba, Jessica A. Pollard, Janice F. Olson, Laura K. Gowans, Rebecca E. McFall, Narayana Gowda, Michael K. Richards, Steven J. Kuerbitz, Alice Lee, Lauren R. Weintraub, Mark E. Weinblatt, Jason M. Fixler, Jill C. Beck, Jennifer J. Clark, Richard Aplenc, Jessica A. Bell, Jeffrey S. Dome, Melissa A. Forouhar, Mohamad H. Badawi, Stefanie R. Lowas, Emad K. Salman, Stuart H. Gold, Jhon A. Guerra, Raul C. Ribeiro, Kenneth B. De Santes, Elizabeth L. Hesketh, Karen S. Fernandez, Jing Chen, Rebecca O. Clark, Jacqueline N. Casillas, Paul J. Wood, Ashley Chopek, Sharon B. Abish, Anna R. Franklin, Yvan Samson, Oussama A. Abla, Anne-Marie R. Langevin, Donna L. Johnston, Shannon M. Cohn, Najat C. Daw, Uma H. Athale, Jennifer J. Greene Welch, Shayna M. Zelcer, Rene Y. McNall-Knapp, Sara Zarnegar-Lumley, David E. Kram, Kathleen J. Yost, Jaime M. Libes, Marianne B. Phillips, Diane Hanna, Samer Zaid Kaylani, Christopher J. Forlenza, Bill H. Chang, Sarah J. McKillop, Sarah E. Leary, Anderson (Andy) B. Collier, Jennifer L. McNeer, Bruno Michon, Conrad V. Fernandez, Kenneth Lieuw
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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