CML Advocates Network

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

Victoria

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

Western Australia

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

Canada

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 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

United States

Alabama

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

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

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

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

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, 80218
Principal Investigator: Jennifer J. Clark

Delaware

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

Florida

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

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

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, 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

Georgia

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

Illinois

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

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

Indiana

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

Kentucky

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

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

Maryland

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

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Principal Investigator: Kenneth Lieuw

Massachusetts

Dana-Farber Cancer Institure
Boston, 02215
Principal Investigator: Jessica A. Polland

Michigan

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

Wayne State University/Karmanos Cancer Institute
Detroit, 48201
Principal Investigator: Jeffrey W. Taub

Minnesota

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

Mississippi

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

Missouri

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

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

Nebraska

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

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

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

New Jersey

Hackensack University Medical Center
Hackensack, 07601
Principal Investigator: Richard A. Drachtman

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

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

New York

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, 10065
Principal Investigator: Christopher J. Forlenza

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

University of Rochester
Rochester,14642
Principal Investigator: Angela R. Girvin

North Carolina

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

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

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

Ohio

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

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

Oklahoma

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

Pennsylvania

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

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

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

Rhode Island

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

South Dakota

Sanford USD Medical Center - Sioux Falls
Sioux Falls57117-5134
Principal Investigator: Kayelyn J. Wagner

Tennessee

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

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

Texas

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

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

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

Utah

Primary Children's Hospital
Salt Lake City, 84113
Principal Investigator: Phillip E. Barnette

Virginia

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

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

Washington

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

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

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

Wisconsin

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