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

Type of study

Treatment discontinuation trial
Pediatric trial

Phase

2

Current status

Recruiting

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 (TKI) in Affecting Treatment-Free Remission (TFR) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML-CP) (ClinicalTrials.gov NCT03817398)

Other trial ID

NCI-2018-03439; U10CA180886

What is the purpose of the study

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

What will happen during the study

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

Key inclusion criteria

This study includes patients of all sexes who:

  • have been diagnosed with chronic phase chronic myeloid leukemia (CP CML) before the age of 18 years
  • have histologic confirmation of CP CML at their original diagnosis
  • are in molecular remission 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
  • have received their current TKI for at least 3 consecutive years at the time of enrollment.

Key exclusion criteria

This study does not include patients with:

  • a known T315I mutation
  • additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive (+) cells at any time before study entry
  • a history of CML in advanced phase (AP) or blast crisis (BC).

Further criteria may apply. Please discuss these with your doctor or study staff.a

Estimated primary completion date

June 2026

Where can I find additional information

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

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

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: Theodore B. Moore

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

Kaiser Permanente-Oakland
Oakland, California, 94611
Principal Investigator: Aarati V. Rao

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: Kelly W. Maloney

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: Ziad A. Khatib

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: Amber M. D’Souza

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

Children’s Hospital of Michigan
Detroit, Michigan, 48201
Principal Investigator: Sureyya Savasan

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201

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: Jill C. Beck

University of Nebraska Medical Center
Omaha, Nebraska, 68198
Principal Investigator: Jill C. Beck

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

Montefiore Medical Cener – Moses Campus
Bronx, New York, 10467
Principal Investigator: Lisa Gennarini

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

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: Thomase W. McLean

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

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 Carbone Cancer Center
Madison, Wisconsin, 53792
Principal Investigator: Kenneth B. De Santes

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