AAML18P1 = Stopping TKI in Affecting Treatment-Free Remission in CP CML [Australia, Canada, Puerto Rico, United States]

Study title

AAML18P1 = Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia

Scientific title

Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia (ClinicalTrials.gov NCT03817398)

Indication and most important inclusion criteria

To be considered for inclusion in this study, patients

- must have been diagnosed with chronic phase chronic myeloid leukemia (CP CML) before the age of 18 years
- must have histologic confirmation of CP CML at their original diagnosis
- must have received their current tyrosine kinase inhibitor (TKI) for at least 3 consecutive years at the time of enrollment
- and must be in molecular remission (MR) with a BCR-ABL1 level of at least 0.01% as measured using the International Scale (IS) by RQ-PCR for at least 2 consecutive years at the time of enrollment

Other criteria may apply.

Short description of intervention

This is a study to assess how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with CML in chronic phase.

Patients stop taking tyrosine kinase inhibitors within 10 days of enrollment. They will be closely monitored for 3 years and treatment outcomes, including quality of life, will be reassessed. Patients who lose their molecular remission may restart TKI medication and will also be closely monitored for 3 years.

Type of study

Treatment discontinuation trial
Pediatric trial

Current status

Recruiting

Study sponsor

Children's Oncology Group in collaboration with
National Cancer Institute (NCI)

Scientific lead / contact

Sonali Chaudhury
Children's Oncology Group

Principal investigator

Sonali Chaudhury
Children's Oncology Group

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Australia

New South Wales

John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, 2310
Principal Investigator: Elizabeth L. Hesketh

The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Principal Investigator: Marianne B. Phillips

Victoria

Monash Medical Center-Clayton Campus
Clayton, 3168
Principal Investigator: Paul J. Wood

Royal Children's Hospital
Parkville, Victoria, 3052
Principal Investigator: Diane Hanna

Western Australia

Perth Children's Hospital
Perth, Western 6009
Principal Investigator: Marianne B. Phillips


Canada

Alberta

University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Principal Investigator: Sarah J. McKillop

Manitoba

CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Principal Investigator: Ashley Chopek

Nova Scotia

IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Principal Investigator: Craig Erker

Ontario

McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Principal Investigator: Uma H. Athale

Children's Hospital
London, Ontario, N6A 5W9
Principal Investigator: Shayna M. Zelcer

Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Principal Investigator: Donna L. Johnston

Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Principal Investigator: Oussama A. Abla

Quebec

The Montreal Children's Hospital of the MUHC
Montreal, H3H 1P3
Principal Investigator: Sharon B. Abish

Centre Hospitalier Universitaire Sainte-Justine
Montreal, QH3T 1C5
Principal Investigator: Yvan Samson

Centre Hospitalier Universitaire de Quebec
Quebec, G1V 4G2
Principal Investigator: Bruno Michon


Puerto Rico


HIMA San Pablo Oncologic Hospital
Caguas, Puerto Rico, 00726
Principal Investigator: Jhon A. Guerra


United States

Alabama

Children's Hospital of Alabama
Birmingham, Alabama, 35233
Principal Investigator: Matthew A. Kutny

USA Health Strada Patient Care Center
Mobile, Alabama, 36604
Principal Investigator: Hamayun Imran

Arizona

Banner Children's at Desert
Mesa, Arizona, 85202
Principal Investigator: Joseph C. Torkildson

Banner University Medical Center – Tucson
Tucson, Arizona, 85719
Principal Investigator: Holly E. Pariury

Arkansas

Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Principal Investigator: David L. Becton

California

Kaiser Permanente Downey Medical Center
Downey, California, 90242
Principal Investigator: Robert M. Cooper

Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
Principal Investigator: Jacqueline N. Casillas

Children's Hospital Los Angeles
Los Angeles, California, 90027
Principal Investigator: Leo Mascarenhas

Mattel Children's Hospital UCLA
Los Angeles, California, 90095
Principal Investigator: William A. May

Valley Children's Hospital
Madera, California, 93636
Principal Investigator: Karen S. Fernandez

Kaiser Permanente-Oakland
Oakland, California, 94611
Principal Investigator: Laura A. Campbell

Children's Hospital of Orange County
Orange, California, 92868
Principal Investigator: Elyssa M. Rubin

Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Principal Investigator: Jay Michael S. Balagtas

University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Principal Investigator: Marcio H. Malogolowkin

Rady Children's Hospital - San Diego
San Diego, California, 92123
Principal Investigator: William D. Roberts

Colorado

Children's Hospital Colorado
Aurora, Colorado, 80045
Principal Investigator: Anna R. Franklin

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
Principal Investigator: Jennifer J. Clark

Connecticut

Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Principal Investigator: Michael S. Isakoff

Delaware

Alfred I duPont Hospital for Children
Wilmington, Delaware19803
Principal Investigator: Scott M. Bradfield

District of Columbia

MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
Principal Investigator: Nina S. Kadan-Lottick

Children's National Medical Center
Washington, District of Columbia, 20010
Principal Investigator: Jeffrey S. Dome

Florida

Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Principal Investigator: Emad K. Salman

University of Florida Health Science Center – Gainesville
Gainesville, Florida, 32610
Principal Investigator: William B. Slayton

Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Principal Investigator: Iftikhar Hanif

Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Principal Investigator: Scott M. Bradfield

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Principal Investigator: Julio C. Barredo

Nicklaus Children's Hospital
Miami, Florida, 33155
Principal Investigator: Enrique A. Escalon

Nemours Children's Hospital
Orlando, Florida, 32827
Principal Investigator: Scott M. Bradfield

Sacred Heart Hospital
Pensacola, Florida, 32504
Principal Investigator: Erlyn C. Smith

Tampa General Hospital
Tampa, Florida, 33606
Principal Investigator: Juan F. Rico

Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Principal Investigator: Don E. Eslin

Saint Mary's Hospital
West Palm Beach, Florida, 33407
Principal Investigator: Narayana Gowda

Georgia

Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Principal Investigator: Daniel J. Bergsagel

Memorial Health University Medical Center
Savannah, Georgia, 31404
Principal Investigator: Andrew L. Pendleton

Hawaii

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Principal Investigator: Wade T. Kyono

Idaho

Saint Luke's Cancer Institute – Boise
Boise, Idaho, 83712
Principal Investigator: Eugenia Chang

Illinois

Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Principal Investigator: Jenna Rossoff

University of Illinois
Chicago, Illinois, 60612
Principal Investigator: Mary L. Schmidt

University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Principal Investigator: Jennifer L. McNeer

Loyola University Medical Center
Maywood, Illinois, 60153
Principal Investigator: Eugene Suh

Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
Principal Investigator: Rebecca E. McFall

Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, 60068
Principal Investigator: Rebecca E. McFall

Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Principal Investigator: Jaime M. Libes

Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Principal Investigator: Gregory P. Brandt

Indiana

Riley Hospital for Children
Indianapolis, Indiana, 46202
Principal Investigator: Sandeep Batra

Iowa

Blank Children's Hospital
Des Moines, Iowa, 50309
Principal Investigator: Samantha L. Mallory

University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Principal Investigator: David S. Dickens

Kentucky

University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
Principal Investigator: James T. Badgett

Norton Children's Hospital
Louisville, Kentucky, 40202
Principal Investigator: Ashok B. Raj

Louisiana

Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
Principal Investigator: Craig Lotterman

Maine

Eastern Maine Medical Center
Bangor, Maine, 04401
Principal Investigator: Nadine P. SantaCruz

Maine Children's Cancer Program
Scarborough, Maine, 04074
Principal Investigator: Eric C. Larsen

Maryland

Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Principal Investigator: Jason M. Fixler

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Principal Investigator: Alan D. Friedman

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Principal Investigator: Rebecca O. Clark

Massachusetts

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Principal Investigator: Jessica A. Pollard

UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
Principal Investigator: Stefanie R. Lowas

Michigan

C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Principal Investigator: Rajen Mody

Michigan State University Clinical Center
East Lansing, Michigan, 48824-7016
Principal Investigator: Laura E. Agresta

Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Principal Investigator: Kathleen J. Yost

Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Principal Investigator: Kathleen J. Yost

Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, 48073
Principal Investigator: Laura K. Gowans

Minnesota

Children's Hospitals and Clinics of Minnesota – Minneapolis
Minneapolis, Minnesota, 55404
Principal Investigator: Michael K. Richards
Mississippi

University of Mississippi Medical Center
Jackson, Mississippi, 39216
Principal Investigator: Anderson (Andy) B. Collier

Missouri

Columbia Regional
Columbia, Missouri, 65201
Principal Investigator: Barbara A. Gruner

Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Principal Investigator: Keith J. August

Washington University School of Medicine
Saint Louis, Missouri, 63110
Principal Investigator: Robert J. Hayashi

Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
Principal Investigator: Robin D. Hanson

Nebraska

Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
Principal Investigator: Minnie Abromowitch

University of Nebraska Medical Center
Omaha, Nebraska, 68198
Principal Investigator: Minnie Abromowitch

Nevada

University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Principal Investigator: Alan K. Ikeda

Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Principal Investigator: Alan K. Ikeda

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Principal Investigator: Alan K. Ikeda

Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Principal Investigator: Alan K. Ikeda

Renown Regional Medical Center
Reno, Nevada, 89502
Principal Investigator: Alan K. Ikeda

New Jersey

Hackensack University Medical Center
Hackensack, New Jersey, 07601
Principal Investigator: Burton E. Appel

Morristown Medical Center
Morristown, New Jersey, 07960
Principal Investigator: Kathryn L. Laurie

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Principal Investigator: Richard A. Drachtman

Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Principal Investigator: Alissa Kahn New York

New York

Albany Medical Center
Albany, New York, 12208
Principal Investigator: Lauren R. Weintraub

Roswell Park Cancer Institute
Buffalo, New York, 14263
Principal Investigator: Clare J. Twist

NYU Winthrop Hospital
Mineola, New York, 11501
Principal Investigator: Chana L. Glasser

The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Principal Investigator: Arlene S. Redner

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer
New York, New York, 10032
Principal Investigator: Justine M. Kahn

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Principal Investigator: Christopher J. Forlenza

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Principal Investigator: Alice Lee

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Principal Investigator: Christopher J. Forlenza

NYP/Weill Cornell Medical Center
New York, New York, 10065
Principal Investigator: Alexander J. Chou

University of Rochester
Rochester, New York, 14642
Principal Investigator: Craig A. Mullen

Stony Brook University Medical Center
Stony Brook, New York, 11794
Principal Investigator: Laura E. Hogan

State University of New York Upstate Medical University
Syracuse, New York, 13210
Principal Investigator: Philip M. Monteleone

New York Medical College
Valhalla, New York, 10595
Principal Investigator: Jessica C. Hochberg

North Carolina

Mission Hospital
Asheville, North Carolina, 28801
Principal Investigator: Douglas J. Scothorn

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Principal Investigator: Stuart H. Gold

Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
Principal Investigator: Joel A. Kaplan

Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Principal Investigator: Jessica A. Bell

East Carolina University
Greenville, North Carolina, 27834
Principal Investigator: Andrea R. Whitfield

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Principal Investigator: David E. Kram

North Dakota

Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Principal Investigator: Samuel J. Milanovich

Ohio

Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Principal Investigator: Steven J. Kuerbitz

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Principal Investigator: Benjamin E. Mizukawa

Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Principal Investigator: Duncan S. Stearns

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Principal Investigator: Rabi Hanna

Nationwide Children's Hospital
Columbus, Ohio, 43205
Principal Investigator: Mark A. Ranalli

Dayton Children's Hospital
Dayton, Ohio, 45404
Principal Investigator: Mukund G. Dole

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
Principal Investigator: Jamie L. Dargart

Oklahoma

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Principal Investigator: Rene Y. McNall-Knapp

Oregon

Legacy Emanuel Children's Hospital
Portland, Oregon, 97227
Principal Investigator: Janice F. Olson

Oregon Health and Science University
Portland, Oregon, 97239
Principal Investigator: Bill H. Chang

Pennsylvania

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Principal Investigator: Jacob A. Troutman

Geisinger Medical Center
Danville, Pennsylvania, 17822
Principal Investigator: Jagadeesh Ramdas

Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Principal Investigator: Lisa M. McGregor

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Principal Investigator: Richard Aplenc

Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Principal Investigator: Gregory E. Halligan

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Principal Investigator: Jean M. Tersak

Rhode Island

Rhode Island Hospital
Providence, Rhode Island, 02903
Principal Investigator: Jennifer J. Welch

South Carolina

Prisma Health Richland Hospital
Columbia, South Carolina, 29203
Principal Investigator: Stuart L. Cramer

BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Principal Investigator: Aniket Saha

South Dakota

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Principal Investigator: Kayelyn J. Wagner

Tennessee

T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403
Principal Investigator: Meghann P. McManus

East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Principal Investigator: Ray C. Pais

Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
Principal Investigator: Raul C. Ribeiro

The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
Principal Investigator: Jennifer A. Domm

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Principal Investigator: Sara Zarnegar-Lumley

Texas

Texas Tech University Health Sciences Center-Amarillo
Amarillo, Texas, 79106
Principal Investigator: Samer Zaid Kaylani

Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Principal Investigator: Shannon M. Cohn

Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Principal Investigator: Nkechi I. Mba

Medical City Dallas Hospital
Dallas, Texas, 75230
Principal Investigator: Stanton C. Goldman

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Principal Investigator: Tamra L. Slone

El Paso Children's Hospital
El Paso, Texas, 79905
Principal Investigator: Ranjan Bista

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
Principal Investigator: Michele S. Redell

M D Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Najat C. Daw

Covenant Children's Hospital
Lubbock, Texas, 79410
Principal Investigator: Kishor M. Bhende

UMC Cancer Center / UMC Health System
Lubbock, Texas, 79415
Principal Investigator: Erin K. Barr

Children's Hospital of San Antonio
San Antonio, Texas, 78207
Principal Investigator: Timothy C. Griffin

Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Principal Investigator: Jose M. Esquilin

University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Principal Investigator: Anne-Marie R. Langevin

Utah

Primary Children's Hospital
Salt Lake City, Utah, 84113
Principal Investigator: Mallorie B. Heneghan

Virginia

Inova Fairfax Hospital
Falls Church, Virginia, 22042
Principal Investigator: Robin Y. Dulman

Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Principal Investigator: Eric J. Lowe

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Principal Investigator: Gita V. Massey

Carilion Children's
Roanoke, Virginia, 24014
Principal Investigator: Erwood G. Edwards

Washington

Seattle Children's Hospital
Seattle, Washington, 98105
Principal Investigator: Sarah E. Leary

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Principal Investigator: Judy L. Felgenhauer

Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Principal Investigator: Robert G. Irwin

Madigan Army Medical Center
Tacoma, Washington, 98431
Principal Investigator: Melissa A. Forouhar

West Virginia

West Virginia University Charleston Division
Charleston, West Virginia, 25304
Principal Investigator: Mohamad H. Badawi

Wisconsin

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Principal Investigator: Kenneth B. De Santes

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Principal Investigator: Michelle A. Manalang


 
   
 

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