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Spots Global Cancer Trial Database for A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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: A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Official Title: A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse

Study ID: NCT04546399

Study Description

Brief Summary: This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To compare rate of minimal residual disease (MRD) negative second remission (Rem-2) after up to two cycles of reinduction with blinatumomab versus (vs.) blinatumomab/nivolumab in Group 1 patients aged \>= 1 to \< 31 years old with first relapse of CD19+ B-ALL. II. To compare event-free survival (EFS) PI (EFS post-induction) between consolidation with blinatumomab vs. blinatumomab/nivolumab in Group 3 patients aged \>= 1 to \< 31 years old with first relapse of CD19+ B ALL. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of blinatumomab/nivolumab in patients aged \>= 1 to \< 31 years old with first relapse of CD19+ B ALL. II. To compare EFS PI between blinatumomab vs. blinatumomab/nivolumab in Group 2 patients aged \>= 1 to \< 31 years old with first relapse of CD19+ B ALL. EXPLORATORY OBJECTIVES: I. In Group 1 patients, compare EFS between blinatumomab monotherapy and blinatumomab/nivolumab arms as compared to similar patients treated on the predecessor trial AALL1331. II. In Group 1 patients, compare toxicity as defined by grade 3 or greater adverse events during the first cycle of blinatumomab or blinatumomab/nivolumab to similar patients treated with block 1 of cytotoxic chemotherapy on the predecessor trial AALL1331. III. In Group 2 patients with MRD \>= 0.1% after vincristine sulfate, dexamethasone, pegylated asparaginase, and doxorubicin hydrochloride (VXLD), compare MRD negative second remission (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and blinatumomab/nivolumab arms. IV. In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety, tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to two cycles of blinatumomab/nivolumab. V. With each Group, perform subset analyses of EFS and overall survival (OS) based on features including degree of marrow disease at relapse, age, sex, body mass index, cytogenetics, site(s) of relapse, percent peripheral blasts at relapse and absolute lymphocyte count at first relapse. OUTLINE: Patients \>= 18 years old with marrow +/- extramedullary (EM) relapse of any duration after initial diagnosis, or patients \< 18 years old with marrow +/- EM relapse \< 24 months after initial diagnosis are assigned to Group 1. Patients \< 18 years old with marrow +/- EM relapse \>= 24 months from initial diagnosis, or all isolated extramedullary (IEM) relapses \>= 1 to \< 31 years old are assigned to Groups 2-3 re-induction. Patients with DS are assigned to Arm G. NOTE: Patients in Group 1 and DS patients with white blood cells (WBC) \>= 30,000/uL, CNS 2/3 disease, or testicular disease must first receive 1 of 3 pre-immunotherapy treatments. PRE-IMMUNOTHERAPY TREATMENT FOR PATIENTS WITH WBC \>= 30,000/uL: Patients receive methotrexate (MTX) intrathecally (IT) or cytarabine IT or intrathecal triple therapy (ITT) consisting of MTX, hydrocortisone sodium succinate, and cytarabine IT at the time of diagnostic lumbar puncture (LP) or on day 1 (if intrathecal therapy is given with relapse diagnostic LP \< 7 days prior to the start of protocol therapy). Patients also receive dexamethasone intravenously (IV) or orally (PO) twice daily (BID) on days 1-5, vincristine sulfate via infusion or IV IV push over 1 minute on day 1. Patients with DS also receive leucovorin calcium PO or IV every 6 hours (q6h) for 2 doses on day 2 or at 24 and 30 hours after each IT administration. Patients should proceed to the next cycle when CNS 1 and no testicular disease is present, no sooner than Day 8 and no later than Day 15. PRE-IMMUNOTHERAPY TREATMENT FOR CNS 2/3 DISEASE: Patients receive MTX IT or cytarabine IT twice weekly (Q2W) for 5-7 doses or Intrathecal Triple Therapy (ITT) IT Q2W for 3-4 doses until patient is CNS 1. Patients with DS also receive leucovorin calcium PO or IV q6h for 2 doses at 24 and 30 hours after each IT administration. Patients should proceed to the next cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 24. PRE-IMMUNOTHERAPY TREATMENT FOR TESTICULAR DISEASE: Patients receive MTX IT, cytarabine IT, or ITT IT on days 1 and 15 (day 1 may be omitted if intrathecal therapy is given with relapse diagnostic LP \< 7 days prior to the start of protocol therapy). Patients with DS also receive leucovorin calcium PO or IV q6h for 2 doses on days 2 and 16 or at 24 and 30 hours after each IT administration. Males with testicular disease at relapse undergo radiation once daily (QD) for a total of 12 fractions over 12 days. Patients should proceed to the next cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 22. GROUP 1: Patients are randomized to Arm A or Arm B. ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1, 15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given \< 7 days prior to the start of this cycle), and MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. ARM B: Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. GROUPS 2-3 REINDUCTION: Patients receive vincristine sulfate via infusion or IV push over 1 minute on days 1, 8, 15, and 22, dexamethasone PO or IV on days 1-14, doxorubicin hydrochloride IV over 1-15 minutes on day 1, MTX IT on days 1, 8, and 29 (day 1 IT may be omitted if intrathecal therapy is given with relapse diagnostic LP \< 7 days prior to the start of this cycle) (days 8 and 29 for CNS 1/2 patients at relapse only), pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 2 and 16, cytarabine IT on days 4 and 11 (CNS 2 patients at relapse only), then Q2W until 3 consecutive samples are clear of blasts, and ITT IT on days 8, 15, 22, and 29 (CNS 3 patients at relapse only). Treatment continues in the absence of disease progression or unacceptable toxicity. GROUP 2: The following patients are randomized to Arm C or Arm D: 1) \>= 1 to \< 31 years old, IEM relapse \< 18 months from diagnosis, regardless of MRD after Re-Induction. 2) \< 18 years old with marrow relapse \>= 24 to \< 36 months from diagnosis regardless of MRD after Re-Induction, 3) \>= 1 to \< 31 years old, IEM relapse \>= 18 months, and MRD \>= 0.1% after Re-Induction, 4) \< 18 years old with marrow relapse \>= 36 months, and MRD \>= 0.1% after Re-Induction. ARM C: Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1 and 2, and MTX IT on days 1 and 15 of cycles 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal MTX is given \< 7 days prior to the start of cycle 1 ). Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. ARM D: Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \< 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \>= 0.01% after cycle 1 proceed to cycle 2. GROUP 3: The following patients are randomized to Arm E or Arm F: 1) \>= 1 to \< 31 years old with IEM relapse \>= 18 months from diagnosis and MRD \< 0.1% after Re-Induction, 2) \< 18 years old with marrow relapse \>= 36 months from diagnosis and MRD \< 0.1% after Re-Induction. ARM E: IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15 (day 1 may be omitted from cycle 1 if intrathecal therapy is given \< 7 days prior to the start of this cycle). Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2. CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide IV over 90-120 minutes on days 43 and 50, thioguanine PO once daily (QD) on days 43-49, and cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 44-47 and 51-54. CNS 1/2 patients at relapse also receive MTX IT on days 1 and 43 and PO q6h for 4 doses on day 22, and leucovorin calcium PO q6h for 2 doses on day 24. CNS 3 patients at relapse also receive ITT IT on days 1 and 43, intermediate dose MTX IV over 36 hours on day 22, and leucovorin calcium IV or PO q6h on days 24 and 25. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15. MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3 patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS ONLY): Beginning between the first and second cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21, vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse undergo cranial radiation in the form of 3-dimensional (D)-conformal radiation therapy (CRT) over 5 days per week for a total of 10 treatments. ARM F: IMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11-25 of cycle 1 and on days 1 and 15 of cycles 2 and 3, and MTX IT on days 1 and 15 (day 1 may be omitted from cycle 1 if intrathecal therapy is given with \< 7 days prior to the start of this cycle). Immunotherapy Cycles 1-2 alternate with Continuation Cycles 1-2. CONTINUATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, MTX PO on days 8, 15, 29, and 36, cyclophosphamide IV over 15-30 minutes on days 43 and 50, etoposide IV over 90-120 minutes on days 43 and 50, thioguanine PO QD on days 43-49, and cytarabine IV over 1-30 minutes or SC on days 44-47 and 51-54. CNS 1/2 patients at relapse also receive MTX IT on days 1 and 43 and PO q6h for 4 doses on day 22, and leucovorin calcium PO q6h for 2 doses on day 24. CNS 3 patients at relapse also receive ITT IT on days 1 and 43, intermediate dose MTX IV over 36 hours on day 22, and leucovorin calcium IV or PO q6h on days 24 and 25. IMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 1 and 15 and MTX IT on days 1 and 15. MAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on days 1-84, MTX IT on day 1 (CNS 1/2 patients at relapse only), ITT IT on day 1 (CNS 3 patients at relapse only), and MTX PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78. Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMORADIATION (FOR CNS 3 PATIENTS): Beginning between the first and second cycles of maintenance therapy, patients receive dexamethasone PO BID on days 1-7 and 15-21, vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and pegaspargase IM or IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse undergo cranial radiation in the form of 3D-CRT over 5 days per week for a total of 10 treatments in the absence of disease progression or unacceptable toxicity. ARM G (DS PATIENTS): Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2, and MTX IT, cytarabine IT, or ITT IT on days 1,15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given \< 7 days prior to the start this cycle 1), MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2, and leucovorin calcium IV or PO q6h for 2 doses on days 2, 16 and 37 of cycle 1 and q6h for 2 doses on days 16 and 37 of cycle 2. Patients with MRD \< 0.01% are eligible to come off protocol therapy to receive Consolidation therapy at the end of Cycle 1, or may choose to proceed to Arm G, Cycle 2. After completion of study treatment, patients are followed up every 3 months for 1 year.

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

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

Providence Alaska Medical Center, Anchorage, Alaska, United States

Kingman Regional Medical Center, Kingman, Arizona, United States

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

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

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

Kaiser Permanente-Anaheim, Anaheim, California, United States

PCR Oncology, Arroyo Grande, California, United States

Kaiser Permanente-Bellflower, Bellflower, California, United States

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

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

Kaiser Permanente-Fontana, Fontana, California, United States

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

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

Kaiser Permanente Los Angeles Medical Center, 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

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

Kaiser Permanente-San Diego Zion, San Diego, California, United States

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

UCSF Medical Center-Mission Bay, San Francisco, 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

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

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

AdventHealth Orlando, Orlando, Florida, United States

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

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

Sacred Heart Hospital, 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

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

Kapiolani Medical Center for Women and Children, 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

Saint Jude Midwest Affiliate, Peoria, Illinois, United States

Riley Hospital for Children, 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

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

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

Maine Children's Cancer Program, Scarborough, Maine, 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

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

Bronson Battle Creek, Battle Creek, Michigan, United States

Beaumont Hospital - Dearborn, Dearborn, Michigan, United States

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

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

Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

Trinity Health Muskegon Hospital, Muskegon, Michigan, United States

Lakeland Hospital Niles, Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores, Michigan, United States

Spectrum Health Reed City Hospital, Reed City, Michigan, United States

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

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

Lakeland Medical Center Saint Joseph, Saint Joseph, Michigan, United States

Marie Yeager Cancer Center, Saint Joseph, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

William Beaumont Hospital - Troy, Troy, Michigan, United States

Metro Health Hospital, Wyoming, 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

University of Mississippi Medical Center, Jackson, Mississippi, 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

Carson Tahoe Regional Medical Center, Carson City, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills, Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States

OptumCare Cancer Care at Charleston, Las Vegas, Nevada, United States

Hope Cancer Care of Nevada, Las Vegas, Nevada, United States

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

Ann M Wierman MD LTD, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States

OptumCare Cancer Care at MountainView, Las Vegas, Nevada, United States

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

Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States

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

Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache, Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States

Hope Cancer Care of Nevada-Pahrump, Pahrump, Nevada, United States

Renown Regional Medical Center, Reno, Nevada, United States

Saint Mary's Regional Medical Center, Reno, Nevada, United States

Cancer Care Specialists - Reno, Reno, Nevada, United States

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

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

Morristown Medical Center, Morristown, New Jersey, United States

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

Rutgers Cancer Institute of New Jersey, 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

Albany Medical Center, Albany, New York, United States

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

Maimonides Medical Center, Brooklyn, New York, United States

NYU Winthrop Hospital, Mineola, New York, United States

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

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Memorial Sloan Kettering Cancer 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

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

Carolinas Medical Center/Levine Cancer Institute, 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 Flower Hospital, Sylvania, Ohio, United States

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

University of Oklahoma Health Sciences Center, Oklahoma City, 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

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

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

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

Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States

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

East Tennessee Childrens Hospital, Knoxville, Tennessee, United States

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

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, 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

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

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

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

Inova Fairfax Hospital, Falls Church, Virginia, United States

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

Overlake Medical Center, Bellevue, Washington, United States

Valley Medical Center, Renton, 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

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States

United Hospital Center, Bridgeport, West Virginia, United States

WVUH-Berkely Medical Center, Martinsburg, West Virginia, United States

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

Camden Clark Medical Center, Parkersburg, West Virginia, United States

University of Wisconsin Carbone Cancer Center, Madison, 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

The Children's Hospital at Westmead, Westmead, New South Wales, Australia

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

Perth Children's Hospital, Perth, Western Australia, Australia

CancerCare Manitoba, Winnipeg, Manitoba, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

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

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec, Quebec, , Canada

University Pediatric Hospital, San Juan, , Puerto Rico

Contact Details

Name: Stacy L Cooper

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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