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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

Official Title: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

Study ID: NCT02883049

Study Description

Brief Summary: This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Chemotherapy drugs, 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) and giving the drugs in different doses and in different combinations may kill more cancer cells.

Detailed Description: PRIMARY OBJECTIVES: I. To determine if the administration of post-Induction age-adjusted intrathecal triple therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) interim maintenance high-dose methotrexate (IMHDM) backbone will improve 5-year disease-free survival (DFS) of children with high-risk (HR) B-acute lymphoblastic leukemia (ALL) compared to age-adjusted intrathecal (IT) methotrexate (MTX). (Completed effective March 19, 2018) II. To determine, in a randomized fashion, if the cyclophosphamide + etoposide containing regimen (Experimental Arm 1) will improve the 4-year DFS of children, adolescents, and young adults with very high-risk (VHR) B-ALL compared to a modified MBFM-IMHDM regimen that contains a second IM (Control Arm). (Completed effective February 15, 2017) SECONDARY OBJECTIVES: I. To determine the toxicity and tolerability of post-Induction age-adjusted ITT compared to age-adjusted IT MTX in children with HR B-ALL. (Completed effective March 19, 2018) II. To determine the toxicity and tolerability of Experimental Arm 1 compared to the Control Arm in children, adolescents, and young adults with VHR B-ALL. (Completed effective February 15, 2017) III. To determine whether a single-arm, modified Induction with limited anthracycline exposure and post-Induction therapy regimen with MBFM-interim maintenance intermediate dose methotrexate (IMIDM) and reduced vincristine (vincristine sulfate)/steroid pulse frequency and enhanced supportive care in children with Down syndrome (DS) and HR B-ALL will result in a \>= 65% 5-year DFS and \< 10% Induction mortality. IV. To describe the outcomes for children and young adults with Philadelphia chromosome (Ph)-like B-ALL and a predicted TKI-sensitive mutation treated with dasatinib plus MBFM-IMHDM. V. To determine the toxicity and tolerability of MBFM-IMIDM in children with DS and HR B-ALL. VI. To estimate overall survival (OS) rates both overall and by regimen a) for HR B-ALL and b) VHR B-ALL patients. VII. To determine the incidence of osteonecrosis (ON), defined by magnetic resonance (MR) imaging, and to characterize the natural history of clinically silent ON in children, adolescents, and young adults 10 years of age and greater and to assess the role of drugs (i.e., asparaginase and methotrexate) in addition to corticosteroids, in the risk for development of ON. (Completed accrual July 2016) VIII. To determine if the prevalence of cognitive deficits measured by CogState, in children (ages 6 to \< 13 years) with HR- and VHR B-ALL at 1 year off therapy, is significantly higher than the normative population (\> 14%) in the following domains: working memory, executive function, visual motor, processing speed, and visual attention. EXPLORATORY OBJECTIVE: I. To determine if the reduction of minimal residual disease (MRD) from end-Induction to end-Consolidation is greater for children, adolescents, and young adults with VHR B-ALL receiving Experimental Arm 1 compared to the Control Arm. (Closed effective October 20, 2017) OUTLINE: INDUCTION THERAPY: Patients without Down syndrome receive induction chemotherapy comprising cytarabine intrathecally (IT) on day 1 (and twice weekly thereafter for CNS2 patients \[except for days 8 and 29\]); vincristine sulfate intravenously (IV) over 1 minute on days 1, 8, 15, and 22; daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-14 (patients under 10 years old) or prednisone PO or IV BID on days 1-28 (patients at least 10 years old); pegaspargase IV over 1-2 hours on day 4; and methotrexate IT on days 8 and 29 for CNS1 and CNS2 patients (plus days 15 and 22 for CNS3 patients). Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Participants are stratified to 1 of 3 disease groups: HR B-ALL, VHR B-ALL and PH-like B-ALL a predicted TKI-sensitive mutation. GROUP I - HR B-ALL: Patients are randomized to 1 of 2 treatment arms. (RANDOMIZATION CLOSED 03/19/2018) CONSOLIDATION THERAPY (C): ARM A HR B-ALL C: Patients receive consolidation therapy comprising cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22; vincristine sulfate IV over 1 minute on days 15, 22, 43, and 50; and pegaspargase IV over 1-2 hours on days 15 and 43. Patients with continuing clinical evidence of testicular leukemia undergo radiotherapy (RT) QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity. ARM B HR B-ALL C: Patients receive consolidation therapy as in Arm I HR B-ALL C. Patients also receive ITT comprising methotrexate, hydrocortisone sodium succinate, and cytarabine on days 1, 8, 15, and 22. Patients with testicular leukemia also undergo RT as in Arm I HR B-ALL C. (CLOSED 03/19/2018) INTERIM MAINTENANCE THERAPY (IM) ARM A HR B-ALL IM: Patients receive IM therapy comprising vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46; methotrexate IT on days 1 and 29; and mercaptopurine PO on days 1-56. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity. ARM B HR B-ALL IM: Patients receive ITT on days 1 and 29 and IM therapy as in Arm I HR-ALL IM. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity. (CLOSED 03/19/2018) DELAYED INTENSIFICATION THERAPY (DI): ARM A HR B-ALL DI: Patients receive DI therapy comprising vincristine sulfate IV over 1 minute on days 1, 8, 15, 43, and 50; dexamethasone PO or IV BID on days 1-7 and 15-21; doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; methotrexate IT on days 1, 29, and 36; pegaspargase IV over 1-2 hours on days 4 and 43; cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO QD on days 29-42. Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity. ARM B HR B-ALL DI: Patients receive ITT on days 1, 29, and 36 and DI therapy as in Arm I HR B-ALL DI. (CLOSED 03/19/2018) MAINTENANCE THERAPY (M): ARM A HR B-ALL M: Patients receive maintenance therapy comprising vincristine sulfate IV over 1 minute on days 1, 29, and 57; methotrexate IT on day 1 (also day 29 of courses 1-4); prednisone PO BID on days 1-5, 29-33 (may receive methylprednisolone IV if PO is not tolerated), and 57-61; mercaptopurine PO QD on days 1-84; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicity. ARM B HR B-ALL M: Patients receive ITT on day 1 (also day 29 of courses 1-4) and maintenance therapy as in Arm I HR B-ALL M. Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicity. (CLOSED 03/19/2018) GROUP II: VHR B-ALL: Patients are randomized to 1 of 3 treatment arms. (RANDOMIZATION CLOSED 02/15/2017) CONSOLIDATION THERAPY PART I: In all arms, patients receive cyclophosphamide IV over 30-60 minutes on day 1; cytarabine IV over 1-30 minutes or SC on days 1-4 and 8-11; mercaptopurine PO QD on days 1-14; methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3 patients); vincristine sulfate IV over 1 minute on days 15 and 22; and pegaspargase IV over 1-2 hours on day 15. Patients with continuing clinical evidence of testicular leukemia undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY PART II: ARM A VHR B-ALL C (CONTROL ARM): Patients receive consolidation therapy comprising cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; mercaptopurine PO QD on days 29-42; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. ARM B VHR B-ALL C (EXPERIMENTAL ARM 1): Patients receive consolidation therapy comprising cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on days 29-33; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED 02/15/2017) ARM C VHR B-ALL C (EXPERIMENTAL ARM 2): Patients receive clofarabine IV over 2 hours on days 29-33 and consolidation therapy as in Arm B VHR B-ALL C. (CLOSED 9/12/2014) INTERIM MAINTENANCE THERAPY PART I: In all arms, patients receive vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43; high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46; mercaptopurine PO QD on days 1-56; and methotrexate IT on days 1 and 29. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION THERAPY PART I: In all arms, patients receive vincristine sulfate IV over 1 minute on days 1, 8, and 15; dexamethasone PO or IV BID on days 1-7 and 15-21; doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; methotrexate IT on day 1; and pegaspargase IV over 1-2 hours on day 4. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION THERAPY PART II: ARM A VHR B-ALL DI (CONTROL ARM): Patients receive DI therapy comprising cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; thioguanine PO QD on days 29-42; methotrexate IT on days 29 and 36; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. ARM B VHR B-ALL DI (EXPERIMENTAL ARM 1): Patients receive DI therapy comprising cyclophosphamide IV over 15-30 minutes on days 29-33; etoposide IV over 60-120 minutes on days 29-33; methotrexate IT on days 29 and 36; vincristine sulfate IV over 1 minute on days 43 and 50; and pegaspargase IV over 1-2 hours on day 43. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED 02/15/2017) ARM C VHR B-ALL DI (EXPERIMENTAL ARM 2): Patients receive clofarabine IV over 2 hours on days 29-33 and DI therapy as in Arm II B VHR B-ALL DI. (Closed as of 9/12/2014) INTERIM MAINTENANCE THERAPY PART II: In all arms, patients receive vincristine sulfate IV over 1 minute and methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity. MAINENTANCE THERAPY: Patients with CNS3 disease at diagnosis undergo RT QD over 4 weeks (10 fractions total). In all arms, patients receive vincristine sulfate IV over 1 minute on days 1, 29, and 57; prednisone PO BID on days 1-5, 29-33, and 57-61 (may receive methylprednisolone IV if PO is not tolerated); methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (except on methotrexate IT days); mercaptopurine PO QD on days 1-84; methotrexate IT on day 1 (also day 29 of courses 1 and 2 for CNS patients who did not undergo RT). Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicities. GROUP III: PH-LIKE PREDICTED TKI-SENSITIVE KINASE MUTATION: CONSOLIDATION THERAPY: Patients receive dasatinib PO QD on days 1-56, cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32 and 36-39, mercaptopurine PO on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15 and 22 (days 1 and 8 only for CNS3 patients), vincristine sulfate IV over 1 minute on days 15, 22, 43 and 50, and pegaspargase IV over 1-2 hours on days 15 and 43. Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity. INTERIM MAINTENANCE THERAPY I: Patients receive dasatinib PO QD on days 1-63, vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46, methotrexate IT on days 1 and 29, and mercaptopurine PO on days 1-56. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION THERAPY: Patients receive dasatinib PO QD on days 1-56, vincristine sulfate IV over 1 minute on days 1, 8, 15, 43, and 50, dexamethasone PO or IV on days 1-7 and 15-21, doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8 and 15, methotrexate IT on days 1, 29 and 36, pegaspargase IV over 1-2 hours on days 4 and 43, cyclophosphamide IV over 30-60 minutes day 29, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, and thioguanine PO on days 29-42. Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity. INTERIM MAINTENANCE THERAPY II: Patients dasatinib PO QD on days 1-56, vincristine sulfate IV over 1 minute days 1, 11, 21, 31, and 41, methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on days 1, 11, 21, 31 and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2 hours days 2 and 22. MAINTENANCE THERAPY: Patients receive dasatinib PO QD on days 1-84, vincristine sulfate IV over 1 minute on days 1, 29 and 57, prednisone PO BID or IV 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 (omit on days when MTX \[IT\] is given), mercaptopurine PO on days 1-84, methotrexate IT on day 1 (also day 29 of course 1 and 2, for patients who did not receive CNS radiation). Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicities. Participants with Down syndrome are assigned to DS HR B-ALL: INDUCTION THERAPY: All patients receive cytarabine IT on day 1; vincristine sulfate IV over 1 minute on days 1 and 8, dexamethasone PO or IV BID (patients under 10 years old) or prednisone PO BID (patients at least 10 years old) on days 1-14 (may receive methylprednisolone IV if PO is not tolerated), pegaspargase IV over 1-2 hours on day 4; methotrexate IT on day 8; and leucovorin calcium PO on days 10-11. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. RAPID EARLY RESPONDERS (RER): Patients receive induction therapy comprising vincristine sulfate IV over 1 minute on days 15 and 22; dexamethasone PO BID (patients under 10 years old) or prednisone PO BID (patients at least 10 years old) on days 15-28; methotrexate IT on day 29 (also days 15 and 22 for CNS3 patients); and leucovorin calcium PO on days 31-32 (also days 17-18 and 24-25 for CNS3 patients). Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. SLOW EARLY RESPONDERS (SER): Patients receive daunorubicin hydrochloride IV over 1-15 minutes on day 15 and Induction therapy as RER patients. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: All patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO QD on days 1-14 and 29-42; vincristine sulfate IV over 1 minute on days 15, 22, 43, and 50; pegaspargase IV over 1-2 hours on days 15 and 43; methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3 patients); and leucovorin calcium PO on days 3-4, 10-11, 17-18, and 24-25. Patients with continuing clinical evidence of testicular leukemia undergo RT QD, 5 days a week, for approximately 2½ weeks (12 fractions total). Treatment continues for 56 days in the absence of disease progression or unacceptable toxicity. INTERIM MAINTENANCE THERAPY: Patients receive vincristine sulfate IV over 1 minute on days 1, 15, 29, and 43; intermediate dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium PO or IV on days 2-3, 17-18, 31-32, and 45-46; mercaptopurine PO QD on days 1-56; and methotrexate IT on days 1 and 29. Treatment continues for 63 days in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION THERAPY: Patients receive vincristine sulfate IV over 1 minute on days 1, 8, 15, 43, and 50; dexamethasone PO BID or IV on days 1-7 and 15-21; doxorubicin hydrochloride IV over 1-15 minutes on days 1, 8, and 15; pegaspargase IV over 1-2 hours on days 4 and 43; cyclophosphamide IV over 30-60 minutes on day 29; thioguanine PO QD on days 29-42; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; methotrexate IT on days 1, 29, and 36; and leucovorin calcium PO on days 3-4, 31-32 and 38-39. MAINTENANCE THERAPY: Patients with CNS3 disease undergo RT QD, 5 days a week, for 2 weeks (10 fractions total). Patients receive vincristine sulfate IV over 1 minute on day 1; prednisone PO BID or IV on days 1-5 (may receive methylprednisolone IV if PO not tolerated); methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO QD on days 1-84; and methotrexate IT on day 1 (also day 29 of courses 1-4 for CNS3 patients who did not undergo RT). Treatment repeats every 12 weeks for 2 years (females) or 3 years (males) in the absence of disease progression or unacceptable toxicities. After completion of study treatment, patients are followed up periodically for 10 years.

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

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

Palms West Radiation Therapy, Loxahatchee Groves, 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 School of Medicine, 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

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States

Bronson Methodist Hospital, 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

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

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

NYU Langone Hospital - Long Island, 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

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

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

Rhode Island Hospital, Providence, Rhode Island, 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

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 - University Hospital, 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

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

Perth Children's Hospital, 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: Michael J Burke

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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