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Spots Global Cancer Trial Database for Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Official Title: Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)

Study ID: NCT01190930

Study Description

Brief Summary: This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). 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. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Detailed Description: PRIMARY OBJECTIVES: l. To determine if a maintenance regimen containing weekly oral methotrexate at 40 mg/m\^2/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m\^2/week in the average-risk (AR) subset of patients with standard-risk B-precursor acute lymphoblastic leukemia (ALL). (Complete effective January 13, 2017) II. To determine whether a reduced-pulses maintenance regimen with vincristine (vincristine sulfate)/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with standard risk B-precursor ALL. III. To confirm that patients in the low-risk (LR) subset of standard risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5 year DFS of at least 95% with either a P9904 based regimen that includes 6 courses of intermediate dose (1 g/m\^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during maintenance (Arm LR-C). IV. To provide standardized treatment and enhanced supportive care to children with standard-risk (SR) Down syndrome B-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup. V. To improve understanding of the biology of localized B-lineage lymphoblastic lymphoma (B-LLy) and Down syndrome (DS) B-LLy by obtaining biologic data, including fluorescence in situ hybridization (FISH) for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research. VI. To describe the 5-year event free survival (EFS) and overall survival (OS) of patients with Murphy stage I and II B-LLy receiving modified AR B-ALL therapy. SECONDARY OBJECTIVES: I. To assess the burden of AR B-ALL therapy as measured by surveys of the child's quality of life, missed days of school/daycare/work by children and parents, family functioning, parental perception of the child's health vulnerability, physical functioning, and emotional distress, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of April 19, 2013) II. To characterize the onset, severity, and natural history of vincristine associated neuropathy by physical therapists (or occupational therapists) in children undergoing therapy for AR B-ALL, 1) overall at different time points during and at the end of therapy, and by 2) comparing children randomized to every 4 week vs. every 12 week dexamethasone/vincristine pulses during maintenance. (Closed to accrual as of March 15, 2013) TERTIARY OBJECTIVES: I. To explore the correlation of minimal marrow disease (MMD) at diagnosis and outcome for patients with B-LLy. (Closed effective Amendment #5) OUTLINE: All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate\* on days 8 and 29. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 \[\> 25% lymphoblasts\] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study. NOTE: \*Patients with DS also receive oral leucovorin calcium every 12 hours on days 10-11 and 31-32. STANDARD-RISK WITH DOWN SYNDROME: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years (timed from the start of interim maintenance I therapy). B-LLy: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; IT methotrexate on days 1, 8, and 15; and leucovorin calcium PO every 12 hours on days 3-4, 10-11, and 17-18. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on day 31; and leucovorin calcium PO every 12 hours on days 36-34. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 29-32 and 33-39; IT methotrexate on days 1 and 29; and leucovorin calcium PO every 12 hours on days 3-4 and 31-32. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41; IT methotrexate on days 1 and 31; and leucovorin calcium PO every 12 hours on days 3-4 and 33-34. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 4 weeks for 2 years (timed from the start of interim maintenance I therapy). AVERAGE-RISK: Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; mercaptopurine PO on days 1-28; and IT methotrexate on days 1, 8, and 15.Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29. Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients are randomized to 1 of 4 maintenance therapy treatment arms. Arm A: Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Arm B: Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Arm C: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Arm D: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. In all arms, maintenance therapy courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy). LOW-RISK: Patients are randomized to 1 of 2 treatment arms. Arm I (LR-M): Consolidation therapy (19 weeks): Beginning one week after completion of induction therapy, patients receive vincristine sulfate IV on days 15, 22, 78, and 85; methotrexate IV over 24 hours and IT methotrexate on days 8, 29, 50, 71, 92, and 113; leucovorin calcium PO or IV on days 9-10, 30-31, 51-52, 72-73, 93-94, and 114-115; dexamethasone PO BID or IV on days 15-21 and 78-84; and PO mercaptopurine on days 1-133.Maintenance therapy: Patients receive vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate\* PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, and 106; and mercaptopurine PO on days 1-112. Courses repeat every 16 weeks. Patients also receive IT methotrexate on days 1 and 85 (courses 1 and 4), day 57 (courses 2 and 5), or day 29 (courses 3 and 6). Patients then receive course 7 comprising vincristine sulfate IV on days 1 and 8; dexamethasone PO BID on days 1-7; methotrexate PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, and 64; and mercaptopurine PO on days 1-70. Treatment continues for 2 and ½ years (timed from the date of diagnosis).NOTE: \*Patients do not receive methotrexate PO on the days that they receive IT methotrexate. Arm II (LR-C): Consolidation therapy (4 weeks): Patients receive vincristine sulfate IV on day 1; oral mercaptopurine on days 1-28; and IT methotrexate on days 1, 8, and 15. Interim maintenance I therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on day 31. Delayed-intensification therapy (8 weeks): Patients receive dexamethasone PO or IV BID on days 1-7 and 15-21; vincristine sulfate IV and doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on day 4; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and IT methotrexate on days 1 and 29.Interim maintenance II therapy (8 weeks): Patients receive vincristine sulfate IV and methotrexate IV over 2-15 minutes on days 1, 11, 21, 31, and 41 and IT methotrexate on days 1 and 31. Maintenance therapy: Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1. Courses repeat every 12 weeks for 2 years for girls and for 3 years for boys (timed from the start of interim maintenance I therapy). After completion of study treatment, patients are followed up periodically for 10 years from study entry.

Keywords

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

USA Health Strada Patient Care Center, Mobile, Alabama, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Banner Children's at Desert, Mesa, Arizona, United States

Phoenix Childrens Hospital, Phoenix, Arizona, United States

Banner University Medical Center - Tucson, Tucson, Arizona, United States

Arkansas Children's Hospital, Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center, Downey, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Loma Linda University Medical Center, Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Cedars Sinai Medical Center, Los Angeles, California, United States

Mattel Children's Hospital UCLA, Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Valley Children's Hospital, Madera, California, United States

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

Kaiser Permanente-Oakland, Oakland, California, United States

Children's Hospital of Orange County, Orange, California, United States

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States

Sutter Medical Center Sacramento, Sacramento, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Rady Children's Hospital - San Diego, San Diego, California, United States

Naval Medical Center -San Diego, San Diego, California, United States

UCSF Medical Center-Parnassus, San Francisco, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Santa Barbara Cottage Hospital, Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States

Children's Hospital Colorado, Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States

MedStar Georgetown University Hospital, Washington, District of Columbia, United States

Children's National Medical Center, Washington, District of Columbia, United States

Broward Health Medical Center, Fort Lauderdale, Florida, United States

Lee Memorial Health System, Fort Myers, Florida, United States

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

Nicklaus Children's Hospital, Miami, Florida, United States

Miami Cancer Institute, Miami, Florida, United States

AdventHealth Orlando, Orlando, Florida, United States

Arnold Palmer Hospital for Children, Orlando, Florida, United States

Nemours Children's Clinic - Orlando, Orlando, Florida, United States

Orlando Health Cancer Institute, Orlando, Florida, United States

Nemours Children's Hospital, Orlando, Florida, United States

Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States

Tampa General Hospital, Tampa, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States

Saint Mary's Hospital, West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

Augusta University Medical Center, Augusta, Georgia, United States

Memorial Health University Medical Center, Savannah, Georgia, United States

University of Hawaii Cancer Center, Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Tripler Army Medical Center, Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

University of Illinois, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, United States

Advocate Children's Hospital-Park Ridge, Park Ridge, Illinois, United States

Advocate Lutheran General Hospital, Park Ridge, Illinois, United States

Saint Jude Midwest Affiliate, Peoria, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, United States

Blank Children's Hospital, Des Moines, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Norton Children's Hospital, Louisville, Kentucky, United States

Tulane University Health Sciences Center, New Orleans, Louisiana, United States

Children's Hospital New Orleans, New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Eastern Maine Medical Center, Bangor, Maine, United States

Maine Children's Cancer Program, Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Tufts Children's Hospital, Boston, Massachusetts, United States

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Ascension Saint John Hospital, Detroit, Michigan, United States

Michigan State University Clinical Center, East Lansing, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

Kalamazoo Center for Medical Studies, Kalamazoo, Michigan, United States

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan, United States

William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Columbia Regional, Columbia, Missouri, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States

Summerlin Hospital Medical Center, Las Vegas, Nevada, United States

Nevada Cancer Research Foundation NCORP, Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Saint Barnabas Medical Center, Livingston, New Jersey, United States

Morristown Medical Center, Morristown, New Jersey, United States

Saint Peter's University Hospital, New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States

Overlook Hospital, Summit, New Jersey, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Albany Medical Center, Albany, New York, United States

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

Brooklyn Hospital Center, Brooklyn, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

NYU Winthrop Hospital, Mineola, New York, United States

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

Mount Sinai Hospital, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

NYP/Weill Cornell Medical Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

State University of New York Upstate Medical University, Syracuse, New York, United States

New York Medical College, Valhalla, New York, United States

Mission Hospital, Asheville, North Carolina, United States

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States

Duke University Medical Center, Durham, North Carolina, United States

East Carolina University, Greenville, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

Sanford Broadway Medical Center, Fargo, North Dakota, United States

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Nationwide Children's Hospital, Columbus, Ohio, United States

Dayton Children's Hospital, Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

Mercy Children's Hospital, Toledo, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States

Legacy Emanuel Children's Hospital, Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States

Oregon Health and Science University, Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Penn State Children's Hospital, Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Prisma Health Richland Hospital, Columbia, South Carolina, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States

Greenville Cancer Treatment Center, Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

T C Thompson Children's Hospital, Chattanooga, Tennessee, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee, United States

Saint Jude Children's Research Hospital, Memphis, Tennessee, United States

The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Texas Tech University Health Sciences Center-Amarillo, Amarillo, Texas, United States

Dell Children's Medical Center of Central Texas, Austin, Texas, United States

Driscoll Children's Hospital, Corpus Christi, Texas, United States

Medical City Dallas Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

El Paso Children's Hospital, El Paso, Texas, United States

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

Cook Children's Medical Center, Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

M D Anderson Cancer Center, Houston, Texas, United States

Covenant Children's Hospital, Lubbock, Texas, United States

UMC Cancer Center / UMC Health System, Lubbock, Texas, United States

Vannie Cook Children's Clinic, McAllen, Texas, United States

Children's Hospital of San Antonio, San Antonio, Texas, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Scott and White Memorial Hospital, Temple, Texas, United States

Primary Children's Hospital, Salt Lake City, Utah, United States

University of Vermont and State Agricultural College, Burlington, Vermont, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Inova Fairfax Hospital, Falls Church, Virginia, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia, United States

Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Carilion Children's, Roanoke, Virginia, United States

Seattle Children's Hospital, Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

West Virginia University Charleston Division, Charleston, West Virginia, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States

University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales, Australia

Sydney Children's Hospital, Randwick, New South Wales, Australia

Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

Royal Children's Hospital-Brisbane, Herston, Queensland, Australia

Queensland Children's Hospital, South Brisbane, Queensland, Australia

Women's and Children's Hospital-Adelaide, North Adelaide, South Australia, Australia

Monash Medical Center-Clayton Campus, Clayton, Victoria, Australia

Royal Children's Hospital, Parkville, Victoria, Australia

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Alberta Children's Hospital, Calgary, Alberta, Canada

University of Alberta Hospital, Edmonton, Alberta, Canada

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Children's Hospital, London, Ontario, Canada

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Hospital for Sick Children, Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Our Lady's Children's Hospital, Dublin, Co Dublin, Ireland

Starship Children's Hospital, Grafton, Auckland, New Zealand

Christchurch Hospital, Christchurch, , New Zealand

San Jorge Children's Hospital, San Juan, , Puerto Rico

University Pediatric Hospital, San Juan, , Puerto Rico

Swiss Pediatric Oncology Group - Geneva, Geneva, , Switzerland

Swiss Pediatric Oncology Group - Lausanne, Lausanne, , Switzerland

Contact Details

Name: Anne L Angiolillo

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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