Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients with Down Syndrome

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive91 days to 3 yearsAAML1531
NCI-2015-00324, NCT02521493

Trial Description

Summary

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease [MRD]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.

II. To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS.

EXPLORATORY OBJECTIVES:

I. To determine the extent to which elimination of HD Ara-C from the treatment of standard risk DS AML decreases adverse events and resource utilization.

II. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number of days per patient spent on protocol therapy compared to predecessor study AAML0431.

III. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the average number of days of hospitalization per patient compared to predecessor studies AAML0431 and A2971.

IV. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease in the number (per patient) and rate (per duration of treatment) of sterile site infections compared to the predecessor study AAML0431.

V. To determine if elimination of HD Ara-C from treatment of standard risk DS AML results in a significant decrease of resource utilization by AML treatment compared to the predecessor study AAML0431.

VI. To compare the feasibility and analytical characteristics of flow cytometry, polymerase chain reaction (PCR) and targeted error-corrected sequencing of GATA binding protein 1 (globin transcription factor 1) (GATA1) mutations as methods to detect MRD in DS AML.

VII. To establish a DS AML cell bank of viably frozen bone marrow samples collected at the end of induction and corresponding non-tumor deoxyribonucleic acid (DNA) samples collected at end of Induction 1.

OUTLINE:

INDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days.

Patients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I.

ARM A (STANDARD RISK):

INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.

INDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.

INTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.

INTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.

ARM B (HIGH RISK):

INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours every 12 (Q12) hours on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.

INTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours and etoposide IV over 60-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.

INTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours Q12 hours on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.

After completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 10 years, and then at relapse.

Eligibility Criteria

Inclusion Criteria:

Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization [FISH])

Patients with previously untreated de novo AML who meet the criteria for AML with >= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification

Patients with cytopenias and/or bone marrow blasts who do not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of < 20% marrow blasts are eligible if they meet the criteria for a diagnosis of myelodysplastic syndrome (MDS)

Patients with a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention), who:

Are > 8 weeks since resolution of transient myeloproliferative disease (TMD) with >= 5% blasts, OR

Patients sho have an increasing blast count (>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart

Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD

There are no minimal organ function requirements for enrollment on this study

Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria

Each patient’s 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 subjects research must be met

Exclusion Criteria:

Patients with promyelocytic leukemia (French-American-British [FAB] M3)

Prior therapy

Patients =< 30 days from the last dose of cytarabine used for treatment of TMD

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Childrens Oncology Group

  • National Cancer Institute
Jason Noah Berman, Principal Investigator

Trial Sites

U.S.A.

Alabama
Birmingham

Children's Hospital of Alabama

Alyssa Terry Reddy
Ph: 205-638-9285

Alyssa Terry Reddy
Principal Investigator

Alaska
Anchorage

Providence Alaska Medical Center

Brenda J. Wittman
Ph: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Brenda J. Wittman
Principal Investigator

Arizona
Mesa

Cardon Children's Medical Center

Erlyn C. Smith
Ph: 602-747-9738

Erlyn C. Smith
Principal Investigator

Phoenix

Phoenix Childrens Hospital

Jessica Boklan
Ph: 602-546-0920

Jessica Boklan
Principal Investigator

California
Downey

Southern California Permanente Medical Group

Robert Michael Cooper
Ph: 626-564-3455

Robert Michael Cooper
Principal Investigator

Loma Linda

Loma Linda University Medical Center

Albert Kheradpour
Ph: 909-558-3375

Albert Kheradpour
Principal Investigator

Los Angeles

Cedars Sinai Medical Center

Fataneh (Fae) Majlessipour
Ph: 310-423-8965

Fataneh (Fae) Majlessipour
Principal Investigator

Children's Hospital Los Angeles

Leo Mascarenhas
Ph: 323-361-4110

Leo Mascarenhas
Principal Investigator

Madera

Children's Hospital Central California

Vonda Lee Crouse
Ph: 866-353-5437

Vonda Lee Crouse
Principal Investigator

Oakland

Children's Hospital and Research Center at Oakland

Carla Barbara Golden
Ph: 510-450-7600

Carla Barbara Golden
Principal Investigator

Kaiser Permanente-Oakland

Steven K. Bergstrom
Ph: 626-564-3455

Steven K. Bergstrom
Principal Investigator

Orange

Children's Hospital of Orange County

Elyssa M. Rubin
Ph: 714-997-3000

Elyssa M. Rubin
Principal Investigator

Palo Alto

Lucile Packard Children's Hospital Stanford University

Sheri Lee Spunt
Ph: 650-498-7061
Email: ccto-office@stanford.edu

Sheri Lee Spunt
Principal Investigator

Sacramento

University of California Davis Comprehensive Cancer Center

Marcio Henrique Malogolowkin
Ph: 916-734-3089

Marcio Henrique Malogolowkin
Principal Investigator

San Diego

Naval Medical Center -San Diego

Shelton August Viola
Ph: 619-532-8712

Shelton August Viola
Principal Investigator

Rady Children's Hospital - San Diego

William D. Roberts
Ph: 858-966-5934

William D. Roberts
Principal Investigator

San Francisco

UCSF Medical Center-Mission Bay

Benjamin J. Huang
Ph: 877-827-3222

Benjamin J. Huang
Principal Investigator

Torrance

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Eduard H. Panosyan
Ph: 888-662-8252

Eduard H. Panosyan
Principal Investigator

Colorado
Aurora

Children's Hospital Colorado

Kelly Wilson Maloney
Ph: 720-777-6672

Kelly Wilson Maloney
Principal Investigator

Denver

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Jennifer Jocelyn Clark
Ph: 866-775-6246

Jennifer Jocelyn Clark
Principal Investigator

Connecticut
Hartford

Connecticut Children's Medical Center

Michael Scott Isakoff
Ph: 860-545-9981

Michael Scott Isakoff
Principal Investigator

Delaware
Wilmington

Alfred I duPont Hospital for Children

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

District of Columbia
Washington

Children's National Medical Center

Jeffrey Stuart Dome
Ph: 202-884-2549

Jeffrey Stuart Dome
Principal Investigator

Florida
Fort Myers

Golisano Children's Hospital of Southwest Florida

Emad K. Salman
Ph: 239-343-5333

Emad K. Salman
Principal Investigator

Gainesville

University of Florida

William Birdsall Slayton
Ph: 352-273-8675
Email: trials@cancer.ufl.edu

William Birdsall Slayton
Principal Investigator

Hollywood

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Iftikhar Hanif
Ph: 954-265-2234

Iftikhar Hanif
Principal Investigator

Jacksonville

Nemours Children's Clinic-Jacksonville

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

Miami

University of Miami Miller School of Medicine-Sylvester Cancer Center

Julio Cesar Barredo
Ph: 305-243-2647

Julio Cesar Barredo
Principal Investigator

Orlando

Arnold Palmer Hospital for Children

Vincent Ferdinando Giusti
Ph: 321-843-2584

Vincent Ferdinando Giusti
Principal Investigator

Florida Hospital Orlando

Fouad M. Hajjar
Ph: 407-303-2090
Email: FH.Cancer.Research@flhosp.org

Fouad M. Hajjar
Principal Investigator

Nemours Children's Hospital

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

Pensacola

Nemours Children's Clinic - Pensacola

Jeffrey H. Schwartz
Ph: 904-697-3529

Jeffrey H. Schwartz
Principal Investigator

Saint Petersburg

Johns Hopkins All Children's Hospital

Jonathan Layne Metts
Email: helpdesk@childrensoncologygroup.org

Jonathan Layne Metts
Principal Investigator

Georgia
Atlanta

Children's Healthcare of Atlanta - Egleston

William G. Woods
Ph: 404-785-1112

William G. Woods
Principal Investigator

Hawaii
Honolulu

Kapiolani Medical Center for Women and Children

Wade T. Kyono
Ph: 808-983-6090

Wade T. Kyono
Principal Investigator

Idaho
Boise

Saint Luke's Mountain States Tumor Institute

Eugenia Chang
Ph: 208-381-3376
Email: mcdonagd@slhs.org

Eugenia Chang
Principal Investigator

Illinois
Chicago

Lurie Children's Hospital-Chicago

Nobuko Hijiya
Ph: 773-880-4562

Nobuko Hijiya
Principal Investigator

University of Chicago Comprehensive Cancer Center

Jennifer Lynn McNeer
Ph: 773-834-7424

Jennifer Lynn McNeer
Principal Investigator

University of Illinois

Mary Lou Schmidt
Ph: 312-355-3046

Mary Lou Schmidt
Principal Investigator

Oak Lawn

Advocate Children's Hospital-Oak Lawn

Rebecca Erin McFall
Ph: 847-723-7570

Rebecca Erin McFall
Principal Investigator

Park Ridge

Advocate Children's Hospital-Park Ridge

Caroline Yingwen Hu
Ph: 847-723-9472

Caroline Yingwen Hu
Principal Investigator

Peoria

Saint Jude Midwest Affiliate

Pedro A. De Alarcon
Ph: 309-655-3258

Pedro A. De Alarcon
Principal Investigator

Springfield

Southern Illinois University School of Medicine

Gregory P. Brandt
Ph: 217-545-7929

Gregory P. Brandt
Principal Investigator

Indiana
Indianapolis

Riley Hospital for Children

Robert J. Fallon
Ph: 800-248-1199

Robert J. Fallon
Principal Investigator

Saint Vincent Hospital and Health Care Center

Bassem I. Razzouk
Ph: 317-338-2194
Email: research@stvincent.org

Bassem I. Razzouk
Principal Investigator

Iowa
Des Moines

Blank Children's Hospital

Wendy Leigh Woods-Swafford
Ph: 515-241-6729

Wendy Leigh Woods-Swafford
Principal Investigator

Iowa City

University of Iowa/Holden Comprehensive Cancer Center

Mariko Sato
Ph: 800-237-1225

Mariko Sato
Principal Investigator

Kentucky
Lexington

University of Kentucky/Markey Cancer Center

Lars Martin Wagner
Ph: 859-257-3379

Lars Martin Wagner
Principal Investigator

Louisville

Norton Children's Hospital

Ashok B. Raj
Ph: 866-530-5516

Ashok B. Raj
Principal Investigator

Louisiana
New Orleans

Ochsner Medical Center Jefferson

Craig Lotterman
Ph: 888-562-4763

Craig Lotterman
Principal Investigator

Maine
Bangor

Eastern Maine Medical Center

Sam Wei Lew
Ph: 800-987-3005

Sam Wei Lew
Principal Investigator

Maryland
Baltimore

Johns Hopkins University/Sidney Kimmel Cancer Center

Patrick A. Brown
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Patrick A. Brown
Principal Investigator

Sinai Hospital of Baltimore

Jason M. Fixler
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Jason M. Fixler
Principal Investigator

Bethesda

Walter Reed National Military Medical Center

Anne Benedicta Warwick
Ph: 301-319-2100

Anne Benedicta Warwick
Principal Investigator

Massachusetts
Boston

Dana-Farber Cancer Institute

Barbara Alsen Degar
Ph: 877-442-3324

Barbara Alsen Degar
Principal Investigator

Floating Hospital for Children at Tufts Medical Center

Michael J. Kelly
Ph: 617-636-5000
Email: ContactUsCancerCenter@TuftsMedicalCenter.org

Michael J. Kelly
Principal Investigator

Springfield

Baystate Medical Center

Joanna G. Luty
Ph: 413-794-3565
Email: tamara.wrenn@baystatehealth.org

Joanna G. Luty
Principal Investigator

Worcester

University of Massachusetts Medical School

Christopher P. Keuker
Ph: 508-856-3216
Email: cancer.research@umassmed.edu

Christopher P. Keuker
Principal Investigator

Michigan
Ann Arbor

C S Mott Children's Hospital

Rajen Mody
Ph: 800-865-1125

Rajen Mody
Principal Investigator

Detroit

Saint John Hospital and Medical Center

Hadi Sawaf
Ph: 313-343-3166

Hadi Sawaf
Principal Investigator

Wayne State University/Karmanos Cancer Institute

Jeffrey Warren Taub
Ph: 313-576-9363

Jeffrey Warren Taub
Principal Investigator

Flint

Hurley Medical Center

Nkechi Onwuzurike
Ph: 888-606-6556

Nkechi Onwuzurike
Principal Investigator

Grand Rapids

Helen DeVos Children's Hospital at Spectrum Health

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Kalamazoo

Bronson Methodist Hospital

Kathleen J. Yost
Ph: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Kathleen J. Yost
Principal Investigator

Minnesota
Minneapolis

Children's Hospitals and Clinics of Minnesota - Minneapolis

Michael Kerr Richards
Ph: 612-813-5193

Michael Kerr Richards
Principal Investigator

Rochester

Mayo Clinic

Carola A. S. Arndt
Ph: 855-776-0015

Carola A. S. Arndt
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

Anderson (Andy) Burton Collier
Ph: 601-815-6700

Anderson (Andy) Burton Collier
Principal Investigator

Missouri
Kansas City

The Childrens Mercy Hospital

Keith Jason August
Ph: 816-234-3265

Keith Jason August
Principal Investigator

Saint Louis

Mercy Hospital Saint Louis

Bethany Graham Sleckman
Ph: 913-948-5588

Bethany Graham Sleckman
Principal Investigator

Washington University School of Medicine

Robert J. Hayashi
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Robert J. Hayashi
Principal Investigator

Nevada
Las Vegas

Children's Specialty Center of Nevada II

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
Principal Investigator

Summerlin Hospital Medical Center

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
Principal Investigator

Sunrise Hospital and Medical Center

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
Principal Investigator

University Medical Center of Southern Nevada

Alan K. Ikeda
Ph: 702-384-0013

Alan K. Ikeda
Principal Investigator

New Hampshire
Lebanon

Dartmouth Hitchcock Medical Center

Sara Chaffee
Ph: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

Sara Chaffee
Principal Investigator

New Jersey
Hackensack

Hackensack University Medical Center

Burton Eliot Appel
Ph: 201-996-2879
Email: Burton.Appel@hackensackmeridian.org

Burton Eliot Appel
Principal Investigator

Morristown

Morristown Medical Center

Steven Lon Halpern
Ph: 973-971-5900

Steven Lon Halpern
Principal Investigator

New Brunswick

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

Richard A. Drachtman
Ph: 732-235-8675

Richard A. Drachtman
Principal Investigator

Paterson

Saint Joseph's Regional Medical Center

Mary Ann Bonilla
Ph: 973-754-2909

Mary Ann Bonilla
Principal Investigator

New York
Albany

Albany Medical Center

Vikramjit Singh Kanwar
Ph: 518-262-3368

Vikramjit Singh Kanwar
Principal Investigator

Buffalo

Roswell Park Cancer Institute

Clare J. Twist
Ph: 877-275-7724

Clare J. Twist
Principal Investigator

Mineola

Winthrop University Hospital

Mark E. Weinblatt
Ph: 866-946-8476

Mark E. Weinblatt
Principal Investigator

New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone

Teena Bhatla
Ph: 212-263-4434
Email: prmc.coordinator@nyumc.org

Teena Bhatla
Principal Investigator

Mount Sinai Hospital

Birte Wistinghausen
Ph: 212-824-7309
Email: CCTO@mssm.edu

Birte Wistinghausen
Principal Investigator

Weill Medical College of Cornell University

Alexander Aledo
Ph: 212-746-1848

Alexander Aledo
Principal Investigator

Rochester

University of Rochester

Jeffrey Robert Andolina
Ph: 585-275-5830

Jeffrey Robert Andolina
Principal Investigator

Syracuse

State University of New York Upstate Medical University

Philip M. Monteleone
Ph: 315-464-5476

Philip M. Monteleone
Principal Investigator

Valhalla

New York Medical College

Jessica Cassara Hochberg
Ph: 914-594-3794

Jessica Cassara Hochberg
Principal Investigator

North Carolina
Asheville

Mission Hospital-Memorial Campus

Douglas James Scothorn
Ph: 828-213-4150

Douglas James Scothorn
Principal Investigator

Chapel Hill

UNC Lineberger Comprehensive Cancer Center

Stuart Harrison Gold
Ph: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu

Stuart Harrison Gold
Principal Investigator

Charlotte

Carolinas Medical Center/Levine Cancer Institute

Joel A. Kaplan
Ph: 704-355-2884

Joel A. Kaplan
Principal Investigator

Novant Health Presbyterian Medical Center

Jessica Amy Fu Bell
Ph: 704-384-5369

Jessica Amy Fu Bell
Principal Investigator

Durham

Duke University Medical Center

Susan G. Kreissman
Ph: 888-275-3853

Susan G. Kreissman
Principal Investigator

Greenville

East Carolina University

Beng Richard Fuh
Ph: 252-744-2161

Beng Richard Fuh
Principal Investigator

North Dakota
Fargo

Sanford Medical Center-Fargo

Samuel Odame Anim
Ph: 701-234-6161

Samuel Odame Anim
Principal Investigator

Ohio
Akron

Children's Hospital Medical Center of Akron

Steven J. Kuerbitz
Ph: 330-543-3193

Steven J. Kuerbitz
Principal Investigator

Cincinnati

Cincinnati Children's Hospital Medical Center

Maureen Megan O'Brien
Ph: 513-636-2799

Maureen Megan O'Brien
Principal Investigator

Cleveland

Cleveland Clinic Foundation

Aron Flagg
Ph: 866-223-8100

Aron Flagg
Principal Investigator

Rainbow Babies and Childrens Hospital

Yousif (Joe) H. Matloub
Ph: 216-844-5437

Yousif (Joe) H. Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Mark Anthony Ranalli
Ph: 614-722-2708

Mark Anthony Ranalli
Principal Investigator

Dayton

Dayton Children's Hospital

Ayman Aly El-Sheikh
Ph: 800-228-4055

Ayman Aly El-Sheikh
Principal Investigator

Toledo

The Toledo Hospital/Toledo Children's Hospital

Dagmar Tichy Stein
Ph: 419-824-1842

Dagmar Tichy Stein
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

Rene Yvonne McNall-Knapp
Ph: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Rene Yvonne McNall-Knapp
Principal Investigator

Oregon
Portland

Legacy Emanuel Children's Hospital

Janice Faye Olson
Ph: 503-413-2560

Janice Faye Olson
Principal Investigator

Oregon Health and Science University

Bill Hoon Chang
Ph: 503-494-1080
Email: trials@ohsu.edu

Bill Hoon Chang
Principal Investigator

Pennsylvania
Hershey

Penn State Children's Hospital

Lisa MacNabb McGregor
Ph: 717-531-6012

Lisa MacNabb McGregor
Principal Investigator

Philadelphia

Children's Hospital of Philadelphia

Richard Aplenc
Ph: 215-590-2810

Richard Aplenc
Principal Investigator

Pittsburgh

Children's Hospital of Pittsburgh of UPMC

Jean M. Tersak
Ph: 412-692-5573

Jean M. Tersak
Principal Investigator

Puerto Rico
San Juan

San Jorge Children's Hospital

Luis A. Clavell
Ph: 787-727-1000

Luis A. Clavell
Principal Investigator

South Carolina
Greenville

BI-LO Charities Children's Cancer Center

Nichole Leigh Bryant
Ph: 864-241-6251

Nichole Leigh Bryant
Principal Investigator

South Dakota
Sioux Falls

Sanford USD Medical Center - Sioux Falls

Kayelyn Jean Wagner
Ph: 605-328-1367

Kayelyn Jean Wagner
Principal Investigator

Tennessee
Chattanooga

T C Thompson Children's Hospital

Manoo G. Bhakta
Ph: 865-331-1812

Manoo G. Bhakta
Principal Investigator

Knoxville

East Tennessee Childrens Hospital

Ray C. Pais
Ph: 865-541-8266

Ray C. Pais
Principal Investigator

Memphis

St. Jude Children's Research Hospital

Jeffrey E. Rubnitz
Ph: 866-278-5833
Email: info@stjude.org

Jeffrey E. Rubnitz
Principal Investigator

Nashville

Vanderbilt University/Ingram Cancer Center

Debra L. Friedman
Ph: 800-811-8480

Debra L. Friedman
Principal Investigator

Texas
Austin

Dell Children's Medical Center of Central Texas

Virginia L. Harrod
Email: helpdesk@childrensoncologygroup.org

Virginia L. Harrod
Principal Investigator

Corpus Christi

Driscoll Children's Hospital

Nkechi Ifeoma Mba
Ph: 361-694-5311

Nkechi Ifeoma Mba
Principal Investigator

Dallas

Medical City Dallas Hospital

Stanton Carl Goldman
Ph: 972-566-5588

Stanton Carl Goldman
Principal Investigator

UT Southwestern/Simmons Cancer Center-Dallas

Tamra Lynn Slone
Ph: 214-648-7097

Tamra Lynn Slone
Principal Investigator

Fort Worth

Cook Children's Medical Center

Kenneth Matthew Heym
Ph: 682-885-2103

Kenneth Matthew Heym
Principal Investigator

Houston

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Karen Ruth Rabin
Ph: 713-798-1354
Email: burton@bcm.edu

Karen Ruth Rabin
Principal Investigator

Lubbock

Covenant Children's Hospital

Kishor Mallikarjun Bhende
Ph: 806-775-8590

Kishor Mallikarjun Bhende
Principal Investigator

University Medical Center

Mohamad M. Al-Rahawan
Ph: 309-655-3258

Mohamad M. Al-Rahawan
Principal Investigator

San Antonio

Children's Hospital of San Antonio

Timothy C. Griffin
Ph: 800-248-1199

Timothy C. Griffin
Principal Investigator

Methodist Children's Hospital of South Texas

Vinod Kumar Gidvani-Diaz
Ph: 210-575-7000

Vinod Kumar Gidvani-Diaz
Principal Investigator

University of Texas Health Science Center at San Antonio

Anne-Marie R. Langevin
Ph: 210-450-3800
Email: CTO@uthscsa.edu

Anne-Marie R. Langevin
Principal Investigator

Utah
Salt Lake City

Primary Children's Hospital

Phillip Evan Barnette
Ph: 801-585-5270

Phillip Evan Barnette
Principal Investigator

Vermont
Burlington

University of Vermont College of Medicine

Alan Charles Homans
Ph: 802-656-4101

Alan Charles Homans
Principal Investigator

Virginia
Falls Church

Inova Fairfax Hospital

Marshall A. Schorin
Ph: 703-208-6650
Email: Stephanie.VanBebber@inova.org

Marshall A. Schorin
Principal Investigator

Norfolk

Childrens Hospital-King's Daughters

Eric Jeffrey Lowe
Ph: 757-668-7243

Eric Jeffrey Lowe
Principal Investigator

Richmond

Virginia Commonwealth University/Massey Cancer Center

Gita Vasers Massey
Ph: 804-628-1939

Gita Vasers Massey
Principal Investigator

Washington
Seattle

Seattle Children's Hospital

Douglas S. Hawkins
Ph: 866-987-2000

Douglas S. Hawkins
Principal Investigator

Spokane

Providence Sacred Heart Medical Center and Children's Hospital

Judy L. Felgenhauer
Ph: 800-228-6618
Email: HopeBeginsHere@providence.org

Judy L. Felgenhauer
Principal Investigator

Tacoma

Madigan Army Medical Center

Melissa Anne Forouhar
Ph: 253-968-0129
Email: mamcdci@amedd.army.mil

Melissa Anne Forouhar
Principal Investigator

West Virginia
Charleston

West Virginia University Charleston

Ashley E. Meyer
Ph: 304-388-9944

Ashley E. Meyer
Principal Investigator

Wisconsin
Milwaukee

Children's Hospital of Wisconsin

Michael James Burke
Ph: 414-805-4380

Michael James Burke
Principal Investigator

Canada

British Columbia
Vancouver

British Columbia Children's Hospital

David Bryan Dix
Ph: 604-875-2345

David Bryan Dix
Principal Investigator

Nova Scotia
Halifax

IWK Health Centre

Conrad Vincent Fernandez
Ph: 902-470-8394

Conrad Vincent Fernandez
Principal Investigator

Ontario
Hamilton

McMaster Children's Hospital at Hamilton Health Sciences

Carol Portwine
Ph: 905-521-2100ext74595

Carol Portwine
Principal Investigator

Kingston

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Mariana Pradier Silva
Ph: 613-544-2630

Mariana Pradier Silva
Principal Investigator

Ottawa

Children's Hospital of Eastern Ontario

Jacqueline Mary Lewis Halton
Ph: 613-738-3931

Jacqueline Mary Lewis Halton
Principal Investigator

Toronto

Hospital for Sick Children

Johann Hans Hitzler
Ph: 416-813-7654ext2027
Email: jason.mcguire@sickkids.ca

Johann Hans Hitzler
Principal Investigator

Quebec
Montreal

Centre Hospitalier Universitaire Sainte-Justine

Yvan Samson
Ph: 514-345-4931

Yvan Samson
Principal Investigator

The Montreal Children's Hospital of the MUHC

Sharon Barbara Abish
Ph: 514-412-4445
Email: info@thechildren.com

Sharon Barbara Abish
Principal Investigator

Quebec

Centre Hospitalier Universitaire de Quebec

Bruno Michon
Ph: 418-525-4444

Bruno Michon
Principal Investigator

New Zealand

Christchurch

Christchurch Hospital

Siobhan Frances Cross
Ph: 03 364 0640

Siobhan Frances Cross
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02521493

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.