Acute Myeloid Leukemia Clinical Trial

The Pediatric Acute Leukemia (PedAL) Screening Trial – A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat – A Leukemia & Lymphoma Society and Children’s Oncology Group Study

Summary

This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials.

II. To maintain a longitudinal and comprehensive registry from relapse in children and young adults with recurrent and refractory leukemia.

OUTLINE:

Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).

After completion of study, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must be less than 22 years of age at the time of study enrollment

Patient must have one of the following:

Patient has known or suspected relapsed/refractory (including primary refractory) AML

This includes isolated myeloid sarcoma
Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome

Patient has known or suspected relapsed ALL that meets one of the following criteria:

Second or greater B-ALL medullary relapse, excluding KMT2Ar.
Any first or greater B-ALL medullary relapse involving KMT2Ar.
Any first or greater T-ALL medullary relapse with or without KMT2Ar.
Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia
Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML
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

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

960

Study ID:

NCT04726241

Recruitment Status:

Recruiting

Sponsor:

LLS PedAL Initiative, LLC

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There are 147 Locations for this study

See Locations Near You

Children's Hospital of Alabama
Birmingham Alabama, 35233, United States
USA Health Strada Patient Care Center
Mobile Alabama, 36604, United States
Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Banner Children's at Desert
Mesa Arizona, 85202, United States
Phoenix Childrens Hospital
Phoenix Arizona, 85016, United States More Info
Site Public Contact
Contact
602-546-0920
Dana B. Salzberg
Principal Investigator
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
Kaiser Permanente Downey Medical Center
Downey California, 90242, United States More Info
Site Public Contact
Contact
626-564-3455
Robert M. Cooper
Principal Investigator
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Valley Children's Hospital
Madera California, 93636, United States
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States
Children's Hospital of Orange County
Orange California, 92868, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto California, 94304, United States
Rady Children's Hospital - San Diego
San Diego California, 92123, United States
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States
Children's Hospital Colorado
Aurora Colorado, 80045, United States More Info
Site Public Contact
Contact
303-764-5056
[email protected]
Kelly E. Faulk
Principal Investigator
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver Colorado, 80218, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
Broward Health Medical Center
Fort Lauderdale Florida, 33316, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers Florida, 33908, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States More Info
Site Public Contact
Contact
302-651-5572
[email protected]
Scott M. Bradfield
Principal Investigator
Nicklaus Children's Hospital
Miami Florida, 33155, United States
Nemours Children's Hospital
Orlando Florida, 32827, United States
Sacred Heart Hospital
Pensacola Florida, 32504, United States More Info
Site Public Contact
Contact
850-416-4611
[email protected]
Erlyn C. Smith
Principal Investigator
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States
Saint Mary's Hospital
West Palm Beach Florida, 33407, United States More Info
Site Public Contact
Contact
561-881-2815
Narayana Gowda
Principal Investigator
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States
Kapiolani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
773-880-4562
Jenna Rossoff
Principal Investigator
University of Illinois
Chicago Illinois, 60612, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
Riley Hospital for Children
Indianapolis Indiana, 46202, United States More Info
Site Public Contact
Contact
800-248-1199
Sandeep Batra
Principal Investigator
Blank Children's Hospital
Des Moines Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States More Info
Site Public Contact
Contact
800-237-1225
David S. Dickens
Principal Investigator
Norton Children's Hospital
Louisville Kentucky, 40202, United States
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States More Info
Site Public Contact
Contact
504-842-8084
[email protected]
Craig Lotterman
Principal Investigator
Maine Children's Cancer Program
Scarborough Maine, 04074, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States
Children's Hospital of Michigan
Detroit Michigan, 48201, United States
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Beaumont Children's Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States More Info
Site Public Contact
Contact
612-813-5193
Michael K. Richards
Principal Investigator
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Columbia Regional
Columbia Missouri, 65201, United States More Info
Site Public Contact
Contact
[email protected]
Barbara A. Gruner
Principal Investigator
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Children's Hospital and Medical Center of Omaha
Omaha Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States More Info
Site Public Contact
Contact
702-384-0013
[email protected]
Alan K. Ikeda
Principal Investigator
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon New Hampshire, 03756, United States More Info
Site Public Contact
Contact
800-639-6918
[email protected]
Angela Ricci
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States
Saint Joseph's Regional Medical Center
Paterson New Jersey, 07503, United States
Albany Medical Center
Albany New York, 12208, United States
Montefiore Medical Center - Moses Campus
Bronx New York, 10467, United States More Info
Site Public Contact
Contact
718-379-6866
[email protected]
Lisa Gennarini
Principal Investigator
Maimonides Medical Center
Brooklyn New York, 11219, United States
NYU Winthrop Hospital
Mineola New York, 11501, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park New York, 11040, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States More Info
Site Public Contact
Contact
[email protected]
Sharon L. Gardner
Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-639-7592
Maria Luisa Sulis
Principal Investigator
University of Rochester
Rochester New York, 14642, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States More Info
Site Public Contact
Contact
800-862-2215
Laura E. Hogan
Principal Investigator
State University of New York Upstate Medical University
Syracuse New York, 13210, United States More Info
Site Public Contact
Contact
315-464-5476
Philip M. Monteleone
Principal Investigator
New York Medical College
Valhalla New York, 10595, United States More Info
Site Public Contact
Contact
914-594-3794
Jessica C. Hochberg
Principal Investigator
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
East Carolina University
Greenville North Carolina, 27834, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Samuel J. Milanovich
Principal Investigator
Rainbow Babies and Childrens Hospital
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States More Info
Site Public Contact
Contact
866-223-8100
[email protected]
Rabi Hanna
Principal Investigator
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
Dayton Children's Hospital
Dayton Ohio, 45404, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo Ohio, 43606, United States More Info
Site Public Contact
Contact
419-824-1842
[email protected]
Jamie L. Dargart
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Rene Y. McNall-Knapp
Principal Investigator
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Lehigh Valley Hospital-Cedar Crest
Allentown Pennsylvania, 18103, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Site Public Contact
Contact
570-271-5251
[email protected]
Jagadeesh Ramdas
Principal Investigator
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Saint Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States More Info
Site Public Contact
Contact
215-427-8991
Gregory E. Halligan
Principal Investigator
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Prisma Health Richland Hospital
Columbia South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States More Info
Site Public Contact
Contact
888-226-4343
[email protected]
Seth E. Karol
Principal Investigator
The Children's Hospital at TriStar Centennial
Nashville Tennessee, 37203, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Site Public Contact
Contact
800-811-8480
Sara Zarnegar-Lumley
Principal Investigator
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
El Paso Children's Hospital
El Paso Texas, 79905, United States More Info
Site Public Contact
Contact
915-298-5444
[email protected]
Ranjan Bista
Principal Investigator
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Najat C. Daw
Principal Investigator
Children's Hospital of San Antonio
San Antonio Texas, 78207, United States More Info
Site Public Contact
Contact
210-704-2894
[email protected]
Timothy C. Griffin
Principal Investigator
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Primary Children's Hospital
Salt Lake City Utah, 84113, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States More Info
Site Public Contact
Contact
703-208-6650
[email protected]
Robin Y. Dulman
Principal Investigator
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Jordyn R. Griffin
Principal Investigator
Carilion Children's
Roanoke Virginia, 24014, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States
Mary Bridge Children's Hospital and Health Center
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States More Info
Site Public Contact
Contact
253-968-6144
[email protected]
Melissa A. Forouhar
Principal Investigator
West Virginia University Healthcare
Morgantown West Virginia, 26506, United States More Info
Site Public Contact
Contact
304-293-7374
[email protected]
Ashley E. Meyer
Principal Investigator
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States More Info
Kenneth B. De Santes
Contact
608-263-6200
[email protected]
Kenneth B. De Santes
Principal Investigator
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
The Children's Hospital at Westmead
Westmead New South Wales, 2145, Australia More Info
Site Public Contact
Contact
61-2-9845 1400
Bhavna Padhye
Principal Investigator
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Perth Children's Hospital
Perth Western Australia, 6009, Australia
Alberta Children's Hospital
Calgary Alberta, T3B 6, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada More Info
Site Public Contact
Contact
902-470-8520
[email protected]
Craig Erker
Principal Investigator
Children's Hospital
London Ontario, N6A 5, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
The Montreal Children's Hospital of the MUHC
Montreal Quebec, H3H 1, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal Quebec, H3T 1, Canada
Starship Children's Hospital
Grafton Auckland, 1145, New Zealand
Christchurch Hospital
Christchurch , 8011, New Zealand
HIMA San Pablo Oncologic Hospital
Caguas , 00726, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

960

Study ID:

NCT04726241

Recruitment Status:

Recruiting

Sponsor:


LLS PedAL Initiative, LLC

How clear is this clinincal trial information?

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