Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT ID: NCT00873093
Last Updated: 2017-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
148 participants
INTERVENTIONAL
2009-03-31
2014-09-30
Brief Summary
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Detailed Description
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I. To estimate the toxicity, second complete response (CR2) rate at the end of Block 1 therapy, and 4-month event-free survival (EFS) for pediatric and young adult patients with relapsed acute lymphoblastic leukemia (ALL) treated with bortezomib in combination with intensive re-induction chemotherapy.
II. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination regimen.
SECONDARY OBJECTIVES:
I. To assess minimal residual disease (MRD) in bone marrow following completion of each therapy block.
II. To assess the feasibility of measuring leukemia initiating cells (LIC) in patient samples before and after chemotherapy.
III. To discover biologic pathways associated with response and drug resistance using gene and protein expression profiles at baseline and following initial exposure to chemotherapy.
IV. To determine if bortezomib inhibits lymphoblast nuclear factor (NF)-kappa (k)-B activity in leukemia patients.
OUTLINE:
REINDUCTION BLOCK 1: Patients receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22; doxorubicin hydrochloride IV over 15 minutes on day 1; prednisone orally (PO) twice daily (BID) on days 1-28; bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11; and pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 2, 8, 15, and 22. Patients with central nervous system (CNS)-negative disease (CNS1 or CNS2) also receive methotrexate IT on days 15 and 29; patients with CNS-positive disease (CNS3) receive triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine IT on days 8, 15, 22, and 29. After completion of reinduction block 1, patients with ALL and M2 or M3 bone marrow proceed directly to reinduction block 2. Patients with ALL and M1 bone marrow or lymphoblastic lymphoma proceed to reinduction block 2 after blood counts recover. Patients with persistent cerebral spinal fluid (CSF) blasts after 6 doses of TIT or patients with progressive lymphoblastic lymphoma are removed from the study.
REINDUCTION BLOCK 2: Patients receive etoposide phosphate IV over 1-2 hours on days 1-5; cyclophosphamide IV over 15-30 minutes on days 1-5; bortezomib IV over 3-5 seconds on days 1, 4, and 8; filgrastim (G-CSF) subcutaneously (SC) or IV daily beginning on day 6 and continuing until blood counts recover\*; high-dose methotrexate IV over 24 hours on day 22; and leucovorin calcium PO or IV every 6 hours on days 23 and 24. Patients with CNS-negative disease also receive methotrexate IT on days 1 and 22; patients with CNS-positive disease receive TIT on days 1 and 22. After completion of reinduction block 2, patients proceed to reinduction block 3 immediately or when blood counts recover. Patients with disease progression are removed from the study.
NOTE: \*Patients do not receive G-CSF on day 8.
REINDUCTION BLOCK 3: Patients receive cytarabine IV over 3 hours BID on days 1, 2, 8, and 9; L-asparaginase IM on days 2 and 9; and G-CSF SC or IV daily beginning on day 10 and continuing until blood counts recover.
After completion of study treatment, patients are followed every 6 months for 3 years and then annually for 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase
Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride
Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
vincristine sulfate
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
prednisone
Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
pegaspargase
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
methotrexate
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
etoposide phosphate
Given IV 100 mg/m2/dose on Days 1-5
cyclophosphamide
Given IV 440 mg/m2/dose on Days 1-5
filgrastim
Given IV or SC 5 micrograms/kg/dose Only on Day 6
leucovorin calcium
Given PO or IV 15mg/m2/dose q6h x 3 doses
laboratory biomarker analysis
Correlative studies
High Dose MTX
IV 5000 mg/m2/dose Block 2: Day 22
Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase
Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride
Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
vincristine sulfate
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
prednisone
Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
pegaspargase
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
methotrexate
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
etoposide phosphate
Given IV 100 mg/m2/dose on Days 1-5
cyclophosphamide
Given IV 440 mg/m2/dose on Days 1-5
filgrastim
Given IV or SC 5 micrograms/kg/dose Only on Day 6
leucovorin calcium
Given PO or IV 15mg/m2/dose q6h x 3 doses
laboratory biomarker analysis
Correlative studies
High Dose MTX
IV 5000 mg/m2/dose Block 2: Day 22
Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase
Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride
Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
vincristine sulfate
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
prednisone
Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
pegaspargase
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
methotrexate
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
etoposide phosphate
Given IV 100 mg/m2/dose on Days 1-5
cyclophosphamide
Given IV 440 mg/m2/dose on Days 1-5
filgrastim
Given IV or SC 5 micrograms/kg/dose Only on Day 6
leucovorin calcium
Given PO or IV 15mg/m2/dose q6h x 3 doses
laboratory biomarker analysis
Correlative studies
High Dose MTX
IV 5000 mg/m2/dose Block 2: Day 22
T-cell ALL (Chemotherapy)
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase
Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride
Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
vincristine sulfate
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
prednisone
Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
pegaspargase
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
methotrexate
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
etoposide phosphate
Given IV 100 mg/m2/dose on Days 1-5
cyclophosphamide
Given IV 440 mg/m2/dose on Days 1-5
filgrastim
Given IV or SC 5 micrograms/kg/dose Only on Day 6
leucovorin calcium
Given PO or IV 15mg/m2/dose q6h x 3 doses
laboratory biomarker analysis
Correlative studies
High Dose MTX
IV 5000 mg/m2/dose Block 2: Day 22
T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.
L-asparaginase
Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride
Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
vincristine sulfate
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
prednisone
Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
pegaspargase
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
methotrexate
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
etoposide phosphate
Given IV 100 mg/m2/dose on Days 1-5
cyclophosphamide
Given IV 440 mg/m2/dose on Days 1-5
filgrastim
Given IV or SC 5 micrograms/kg/dose Only on Day 6
leucovorin calcium
Given PO or IV 15mg/m2/dose q6h x 3 doses
laboratory biomarker analysis
Correlative studies
High Dose MTX
IV 5000 mg/m2/dose Block 2: Day 22
Interventions
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L-asparaginase
Given IM 6000 IU/m2/dose Days 2 and 9
doxorubicin hydrochloride
Given IV 60 mg/m2/dose on Day 1
therapeutic hydrocortisone
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22
vincristine sulfate
Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22
cytarabine
Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9
prednisone
Given PO or IV 40 mg/m2/day on Days 1-28
bortezomib
Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8
pegaspargase
Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22
methotrexate
Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22
etoposide phosphate
Given IV 100 mg/m2/dose on Days 1-5
cyclophosphamide
Given IV 440 mg/m2/dose on Days 1-5
filgrastim
Given IV or SC 5 micrograms/kg/dose Only on Day 6
leucovorin calcium
Given PO or IV 15mg/m2/dose q6h x 3 doses
laboratory biomarker analysis
Correlative studies
High Dose MTX
IV 5000 mg/m2/dose Block 2: Day 22
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pre-B ALL in first early (\< 36 months from diagnosis) isolated bone marrow (BM) or combined BM/extramedullary relapse; or
* T-cell ALL in first isolated BM or combined relapse; or
* T-LL in first relapse
* Patients with leukemia must have had histologic verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis
* Patients with lymphoblastic lymphoma must have measurable disease documented by clinical, radiographic, or histologic criteria; patients must have relapsed or become refractory to conventional therapy
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study
* Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* At least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy
* At least 7 days since the completion of therapy with a biologic agent or donor lymphocyte infusions (DLI); for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
* No evidence of active graft-vs-host disease (GVHD) and \>= 4 months must have elapsed; must not be receiving GVHD prophylaxis
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* 1 month to \< 6 months (0.4 male, 0.4 female)
* 6 months to \< 1 year (0.5 male, 0.5 female)
* 1 to \< 2 years (0.6 male, 0.6 female)
* 2 to \< 6 years (0.8 male, 0.8 female)
* 6 to \< 10 years (1 male, 1 female)
* 10 to \< 13 years (1.2 male, 1.2 female)
* 13 to \< 16 years (1.5 male, 1.4 female)
* \>= 16 years (1.7 male, 1.4 female)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 3 x ULN for age, unless elevation due to leukemia infiltration
* Shortening fraction of \>= 27% by echocardiogram, or
* Ejection fraction of \>= 50% by gated radionuclide study
* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>= 94% at sea level (\> 90% if at high altitude)
* No evidence of acute pulmonary infiltrates on chest radiograph
* Patients with seizure disorder may be enrolled if on allowed anticonvulsants and well controlled; benzodiazepines and gabapentin are acceptable
* Central nervous system (CNS) toxicity =\< grade 2
* Peripheral nervous system (PNS) toxicity \< grade 3
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
* Patients with mature B-cell ALL, ie, leukemia with B-cell (soluble immunoglobulin \[sIg\] positive and kappa or lambda restricted positivity) ALL, with French-American-British (FAB) L3 morphology and/or a myc translocation, are not eligible
* Extramedullary disease status: patients with isolated CNS disease or isolated testicular disease are not eligible
* Patients with known optic nerve and/or retinal involvement are not eligible; patients presenting with visual disturbances should have an ophthalmological exam and, if indicated, an magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement
* Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible
* Cumulative prior anthracycline exposure must not exceed 400 mg/m\^2
* Patients taking anticonvulsants known to activate the cytochrome p450 system, in particular anticonvulsants such as phenytoin, carbamazepine, and phenobarbital, are not eligible; benzodiazepines and gabapentin are acceptable
* Patients who have previously received bortezomib or other proteasome inhibitors are not eligible
* Patients who have a known allergy to doxorubicin, cytarabine, both etoposide and etopophos, boron, mannitol or bortezomib are not eligible
* Patients who cannot receive any asparaginase products (E. Coli, PEG-asparaginase, or Erwinia asparaginase) on this study (eg, due to prior severe pancreatitis, stroke or other toxicity) are not eligible; patients who initially receive asparaginase, but must discontinue due to toxicity, remain eligible; patients with clinically significant prior allergies to pegaspargase are eligible if Erwinia L-asparaginase can be substituted
* Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective birth control method
* Patients must not have received any prior re-induction attempts and must not have received treatment for prior extramedullary relapse; patients with primary induction failure are not eligible
1 Year
31 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Terzah Horton, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Medical Center
Duarte, California, United States
City of Hope
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital and Research Center at Oakland
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Childrens Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
University of California at Davis Cancer Center
Sacramento, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
University of California San Francisco Medical Center-Parnassus
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville South
Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Saint Joseph Children's Hospital of 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 University Medical Center
Savannah, Georgia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Michigan State University Clinical Center
East Lansing, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Columbia Regional
Columbia, Missouri, United States
The Childrens Mercy Hospital
Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Saint John's Mercy Medical Center
St 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
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
University of New Mexico
Albuquerque, New Mexico, United States
Albany Medical Center
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Winthrop University Hospital
Mineola, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
New York University Langone Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Sanford Medical Center-Fargo
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
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Mercy Children's Hospital
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Legacy Emanuel Children's Hospital
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Health Richland
Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Greenville Cancer Treatment Center
Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
T C Thompson Children's Hospital
Chattanooga, Tennessee, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Texas Tech University Health Science Center-Amarillo
Amarillo, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, 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
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Childrens Hospital-King's Daughters
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Clinic Children's Hospital
Roanoke, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University Charleston
Charleston, West Virginia, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Children's Hospital
London, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
San Jorge Children's Hospital
San Juan, , Puerto Rico
Countries
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References
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Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7.
Hanley MJ, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range. J Clin Pharmacol. 2017 Sep;57(9):1183-1193. doi: 10.1002/jcph.906. Epub 2017 Apr 18.
Other Identifiers
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NCI-2011-01908
Identifier Type: REGISTRY
Identifier Source: secondary_id
AALL07P1
Identifier Type: OTHER
Identifier Source: secondary_id
AALL07P1
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-01908
Identifier Type: -
Identifier Source: org_study_id
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