- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190930
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Study Overview
Status
Conditions
- Acute Lymphoblastic Leukemia
- Down Syndrome
- Philadelphia Chromosome Positive
- Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Childhood B Acute Lymphoblastic Leukemia
- Adult B Lymphoblastic Lymphoma
- Ann Arbor Stage I B Lymphoblastic Lymphoma
- Ann Arbor Stage II B Lymphoblastic Lymphoma
- Childhood B Lymphoblastic Lymphoma
- Hypodiploid B Acute Lymphoblastic Leukemia
Intervention / Treatment
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Drug: Cyclophosphamide
- Drug: Mercaptopurine
- Drug: Vincristine Sulfate
- Drug: Doxorubicin Hydrochloride
- Drug: Pegaspargase
- Drug: Thioguanine
- Drug: Cytarabine
- Drug: Methotrexate
- Drug: Leucovorin Calcium
- Drug: Dexamethasone
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Hunter Regional Mail Centre, New South Wales, Australia, 2310
- John Hunter Children's Hospital
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Randwick, New South Wales, Australia, 2031
- Sydney Children's Hospital
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women's Hospital
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Herston, Queensland, Australia, 4029
- Royal Children's Hospital-Brisbane
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South Brisbane, Queensland, Australia, 4101
- Queensland Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital-Adelaide
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Center-Clayton Campus
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6008
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
- Janeway Child Health Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A 5W9
- Children's Hospital
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Co Dublin
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Dublin, Co Dublin, Ireland, 12
- Our Lady's Children's Hospital
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Auckland
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Grafton, Auckland, New Zealand, 1145
- Starship Children's Hospital
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San Juan, Puerto Rico, 00926
- University Pediatric Hospital
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San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
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Geneva, Switzerland, 1205
- Swiss Pediatric Oncology Group - Geneva
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Lausanne, Switzerland, 1011
- Swiss Pediatric Oncology Group - Lausanne
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Mobile, Alabama, United States, 36604
- USA Health Strada Patient Care Center
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Alaska
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Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, United States, 85202
- Banner Children's at Desert
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Phoenix, Arizona, United States, 85016
- Phoenix Childrens Hospital
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Tucson, Arizona, United States, 85719
- Banner University Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, United States, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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Los Angeles, California, United States, 90095
- Mattel Children's Hospital UCLA
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Madera, California, United States, 93636
- Valley Children's Hospital
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Oakland, California, United States, 94609
- UCSF Benioff Children's Hospital Oakland
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Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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Sacramento, California, United States, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, United States, 92123
- Rady Children's Hospital - San Diego
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San Diego, California, United States, 92134
- Naval Medical Center -San Diego
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San Francisco, California, United States, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, United States, 94143
- UCSF Medical Center-Parnassus
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Santa Barbara, California, United States, 93102
- Santa Barbara Cottage Hospital
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Torrance, California, United States, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06520
- Yale University
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Fort Myers, Florida, United States, 33908
- Golisano Children's Hospital of Southwest Florida
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Fort Myers, Florida, United States, 33901
- Lee Memorial Health System
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Gainesville, Florida, United States, 32610
- University of Florida Health Science Center - Gainesville
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, United States, 33155
- Nicklaus Children's Hospital
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, United States, 33176
- Miami Cancer Institute
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Orlando, Florida, United States, 32806
- Orlando Health Cancer Institute
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Orlando, Florida, United States, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Orlando, Florida, United States, 32803
- AdventHealth Orlando
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Orlando, Florida, United States, 32806
- Arnold Palmer Hospital for Children
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Pensacola, Florida, United States, 32504
- Nemours Children's Clinic - Pensacola
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Saint Petersburg, Florida, United States, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Tampa, Florida, United States, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, United States, 33407
- Saint Mary's Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta - Egleston
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Augusta, Georgia, United States, 30912
- Augusta University Medical Center
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, United States, 96859
- Tripler Army Medical Center
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Idaho
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Boise, Idaho, United States, 83712
- Saint Luke's Cancer Institute - Boise
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, United States, 60612
- University of Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital-Chicago
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Oak Lawn, Illinois, United States, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, United States, 60068
- Advocate Lutheran General Hospital
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Park Ridge, Illinois, United States, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, United States, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Iowa
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Des Moines, Iowa, United States, 50309
- Blank Children's Hospital
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, United States, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
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New Orleans, Louisiana, United States, 70118
- Children's Hospital New Orleans
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Scarborough, Maine, United States, 04074
- Maine Children's Cancer Program
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Baltimore, Maryland, United States, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, United States, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States, 02111
- Tufts Children's Hospital
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
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Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, United States, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, United States, 48236
- Ascension Saint John Hospital
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East Lansing, Michigan, United States, 48824-7016
- Michigan State University Clinical Center
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Helen DeVos Children's Hospital at Spectrum Health
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49008
- Kalamazoo Center for Medical Studies
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital-Royal Oak
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Royal Oak, Michigan, United States, 48073
- Beaumont Children's Hospital-Royal Oak
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, United States, 65201
- Columbia Regional
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospitals and Clinics
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, United States, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, United States, 89169
- Nevada Cancer Research Foundation NCORP
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Livingston, New Jersey, United States, 07039
- Saint Barnabas Medical Center
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, United States, 08901
- Saint Peter's University Hospital
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, United States, 07503
- Saint Joseph's Regional Medical Center
-
Summit, New Jersey, United States, 07902
- Overlook Hospital
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
-
-
New York
-
Albany, New York, United States, 12208
- Albany Medical Center
-
Bronx, New York, United States, 10467
- Montefiore Medical Center - Moses Campus
-
Brooklyn, New York, United States, 11201
- Brooklyn Hospital Center
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
Mineola, New York, United States, 11501
- NYU Winthrop Hospital
-
New Hyde Park, New York, United States, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
New York, New York, United States, 10065
- NYP/Weill Cornell Medical Center
-
New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, United States, 14642
- University of Rochester
-
Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
-
Valhalla, New York, United States, 10595
- New York Medical College
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- Mission Hospital
-
Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
-
Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Greenville, North Carolina, United States, 27834
- East Carolina University
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, United States, 44106
- Rainbow Babies and Childrens Hospital
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
-
Toledo, Ohio, United States, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, United States, 43608
- Mercy Children's Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, United States, 74136
- Natalie Warren Bryant Cancer Center at Saint Francis
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
Portland, Oregon, United States, 97227
- Legacy Emanuel Children's Hospital
-
Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, United States, 18017
- Lehigh Valley Hospital - Muhlenberg
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, United States, 17033
- Penn State Children's Hospital
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, United States, 19134
- Saint Christopher's Hospital for Children
-
Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
Columbia, South Carolina, United States, 29203
- Prisma Health Richland Hospital
-
Greenville, South Carolina, United States, 29605
- BI-LO Charities Children's Cancer Center
-
Greenville, South Carolina, United States, 29605
- Greenville Cancer Treatment Center
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- T C Thompson Children's Hospital
-
Knoxville, Tennessee, United States, 37916
- East Tennessee Childrens Hospital
-
Memphis, Tennessee, United States, 38105
- Saint Jude Children's Research Hospital
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, United States, 37203
- The Children's Hospital at TriStar Centennial
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Texas Tech University Health Sciences Center-Amarillo
-
Austin, Texas, United States, 78723
- Dell Children's Medical Center of Central Texas
-
Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
-
Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
-
El Paso, Texas, United States, 79905
- El Paso Children's Hospital
-
Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
Houston, Texas, United States, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Lubbock, Texas, United States, 79410
- Covenant Children's Hospital
-
Lubbock, Texas, United States, 79415
- UMC Cancer Center / UMC Health System
-
McAllen, Texas, United States, 78503
- Vannie Cook Children's Clinic
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
-
San Antonio, Texas, United States, 78207
- Children's Hospital of San Antonio
-
San Antonio, Texas, United States, 78229
- Methodist Children's Hospital of South Texas
-
Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
-
-
Utah
-
Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
-
-
Vermont
-
Burlington, Vermont, United States, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia Cancer Center
-
Falls Church, Virginia, United States, 22042
- Inova Fairfax Hospital
-
Norfolk, Virginia, United States, 23507
- Children's Hospital of the King's Daughters
-
Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University/Massey Cancer Center
-
Roanoke, Virginia, United States, 24014
- Carilion Children's
-
-
Washington
-
Seattle, Washington, United States, 98105
- Seattle Children's Hospital
-
Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
-
Tacoma, Washington, United States, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
-
-
West Virginia
-
Charleston, West Virginia, United States, 25304
- West Virginia University Charleston Division
-
Morgantown, West Virginia, United States, 26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
-
Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932
- Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
- B-ALL patients must have an initial white blood cell count < 50,000/uL
Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
- Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met
Exclusion Criteria:
With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932
- Patients receiving prior steroid therapy may be eligible for AALL0932
Patients with central nervous system 3 (CNS3) leukemia
- CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
- B-ALL patients with testicular leukemia are not eligible for AALL0932
For B-LLy patients the following additional exclusion criteria apply:
- T-lymphoblastic lymphoma
- Morphologically unclassifiable lymphoma
- Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
- CNS3-positive disease or testicular involvement
- M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (risk-adapted chemotherapy)
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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Given IV
Other Names:
Given IT, PO, or IV
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm B (risk-adapted chemotherapy)
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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Given IV
Other Names:
Given IT, PO, or IV
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IT, IV, or SC
Other Names:
Given IT, PO, or IV
Other Names:
Given PO
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm C (risk-adapted chemotherapy)
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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Given IV
Other Names:
Given IT, PO, or IV
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm D (risk-adapted chemotherapy)
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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Given IV
Other Names:
Given IT, PO, or IV
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy.
See detailed description.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IT, IV, or SC
Other Names:
Given IT, PO, or IV
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy.
See detailed description.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Other Names:
Given IV
Other Names:
Given IT, PO, or IV
Other Names:
Given PO
Other Names:
Given orally (PO) or IV
Other Names:
|
Experimental: Arm SR DS (12-week cycle maintenance)
See Detailed Description
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IT, IV, or SC
Other Names:
Given IT, PO, or IV
Other Names:
Given PO
Other Names:
Given orally (PO) or IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
Time Frame: 5.7 years
|
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact.
Five year DFS estimates will be calculated from the point of randomization for both groups.
Two-sided 95% confidence intervals will be calculated.
|
5.7 years
|
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
Time Frame: 5.7 years
|
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact.
Five year DFS estimates will be calculated from the point of randomization for both groups.
Two-sided 95% confidence intervals will be calculated.
|
5.7 years
|
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
Time Frame: 5.1 years
|
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact.
Five year DFS estimates will be calculated from the point of randomization for both groups.
Two-sided 95% confidence intervals will be calculated.
|
5.1 years
|
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
Time Frame: 5.1 years
|
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact.
The 5-year DFS and 95% confidence interval for these patients will be estimated.
|
5.1 years
|
Sample Collection of Central Path Review Slides in B-LLy Patients
Time Frame: Up to 1 month
|
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
|
Up to 1 month
|
Event Free Survival (EFS) for B-LLy Patients
Time Frame: 5 years
|
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact.
The 5-year EFS and 95% confidence interval for these patients will be estimated.
|
5 years
|
Overall Survival (OS) for B-LLy Patients
Time Frame: 5 years
|
OS is calculated as the time from study enrollment to death or date of last contact.
The 5-year OS and 95% confidence interval for these patients will be estimated.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Time Frame: 2 Months
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2 Months
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Time Frame: 1 year
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1 year
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Time Frame: 1.7 years
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1.7 years
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Time Frame: 2.5 years
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2.5 years
|
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Time Frame: 3.2 years
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
3.2 years
|
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Time Frame: 2 Months
|
Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2 Months
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Time Frame: 1 Year
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1 Year
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Time Frame: 1.7 years
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1.7 years
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Time Frame: 2.4 Years
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2.4 Years
|
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Time Frame: 3.2 years
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
3.2 years
|
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School
Time Frame: 2 Months
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2 Months
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School
Time Frame: 1 Year
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1 Year
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School
Time Frame: 1.7 Years
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1.7 Years
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Time Frame: 2.4 years
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2.4 years
|
Burden of Therapy in Boy AR Patients Overall at End of Therapy: School
Time Frame: 3.2 Years
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
3.2 Years
|
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Time Frame: 2 Months
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2 Months
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Time Frame: 1 Year
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1 Year
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Time Frame: 1.7 Years
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
1.7 Years
|
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Time Frame: 2.4 Years
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
2.4 Years
|
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Time Frame: 3.2 Years
|
Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported.
|
3.2 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Time Frame: 1.7 years
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
|
1.7 years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Time Frame: 2.4 Years
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
2.4 Years
|
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Time Frame: 3.2 Years
|
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
3.2 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Time Frame: 1.7 Years
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
|
1.7 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Time Frame: 2.4 Years
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
2.4 Years
|
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Time Frame: 3.2 Years
|
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
3.2 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School
Time Frame: 1.7 Years
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
|
1.7 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School
Time Frame: 2.4 Years
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
2.4 Years
|
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School
Time Frame: 3.2 Years
|
Age standardized Quality of life, measured by the school subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
3.2 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Time Frame: 1.7 Years
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported.
|
1.7 Years
|
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Time Frame: 2.4 Years
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
2.4 Years
|
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Time Frame: 3.2 Years
|
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported.
|
3.2 Years
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
Time Frame: 2 Months
|
Strength in the right ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
2 Months
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
Time Frame: 2 Months
|
Strength in the left ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
2 Months
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
Time Frame: 1 Year
|
Strength in the right ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
1 Year
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Time Frame: 1 Year
|
Strength in the left ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
1 Year
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Time Frame: 2.4 Years
|
Strength in the right ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
2.4 Years
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Time Frame: 2.4 Years
|
Strength in the left ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
2.4 Years
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Time Frame: 4.2 Years
|
Strength in the right ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
4.2 Years
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Time Frame: 4.2 Years
|
Strength in the left ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for the cohort will be reported.
|
4.2 Years
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Time Frame: 2.4 Years
|
Strength in the right ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for each randomization group will be reported.
|
2.4 Years
|
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Time Frame: 2.4 Years
|
Strength in the left ankle dorsiflexors averaged over two measurements.
Age and gender standardized mean and standard deviation for each randomization group will be reported.
|
2.4 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne L Angiolillo, Children's Oncology Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Chromosome Aberrations
- Translocation, Genetic
- Lymphoma
- Leukemia
- Lymphoma, Non-Hodgkin
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Down Syndrome
- Philadelphia Chromosome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Micronutrients
- Antibiotics, Antineoplastic
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Antidotes
- Vitamin B Complex
- Hematinics
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Cyclophosphamide
- Leucovorin
- Calcium
- Levoleucovorin
- Doxorubicin
- Liposomal doxorubicin
- Cytarabine
- Methotrexate
- Vincristine
- Asparaginase
- Mercaptopurine
- Folic Acid
- Calcium, Dietary
- Thioguanine
- Pegaspargase
- 2-Aminopurine
Other Study ID Numbers
- AALL0932 (Other Identifier: CTEP)
- U10CA180886 (U.S. NIH Grant/Contract)
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2011-02599 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000683227
- 11-00080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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