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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00075725
Registration number
NCT00075725
Ethics application status
Date submitted
9/01/2004
Date registered
13/01/2004
Date last updated
27/04/2021
Titles & IDs
Public title
Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
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Scientific title
High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
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Secondary ID [1]
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NCI-2009-00301
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Secondary ID [2]
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AALL0232
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia
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Adult B Acute Lymphoblastic Leukemia
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Childhood B Acute Lymphoblastic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Treatment: Drugs - Prednisone
Treatment: Other - Radiation Therapy
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate
Active comparator: Arm I - Patients in arm I receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
Active comparator: Arm II - Patients in arm II will receive intrathecal cytarabine in week 1; infusions of vincristine and daunorubicin once a week in weeks 1-4; dexamethasone by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate in weeks 2 and 5 or 2-5; and an injection of pegaspargase in week 1.
Experimental: Arm III - Patients in arm III will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5.
Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Experimental: Arm IV - Patients in arm IV will receive cytarabine, vincristine, daunorubicin, and pegaspargase as in groups one and two. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5.
Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IT, SC, or IV
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
Given PO or IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Leucovorin Calcium
Given IV
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IT or IV
Treatment: Drugs: Pegaspargase
Given IM
Treatment: Drugs: Prednisone
Given PO or IV
Treatment: Other: Radiation Therapy
Undergo radiation therapy
Treatment: Drugs: Thioguanine
Given PO
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
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Assessment method [1]
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Event Free Probability.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
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Assessment method [1]
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Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
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Timepoint [1]
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5 Years
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Secondary outcome [2]
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Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
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Assessment method [2]
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Bone marrow MRD status is defined as negative with \< .01 detectable leukemia cells.
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Timepoint [2]
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5 years
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Secondary outcome [3]
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Correlation of Early Marrow Response Status With MRD Positive.
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Assessment method [3]
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Bone marrow status is defined as: M1: \< 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: \> 25% lymphoblasts. Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
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Timepoint [3]
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Day 29
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Secondary outcome [4]
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Correlation of Early Marrow Response Status With MRD Negative.
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Assessment method [4]
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Bone marrow status is defined as: M1: \< 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: \> 25% lymphoblasts. Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells, and negative with \< 0.1 detectable leukemia cells.
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Timepoint [4]
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Day 29
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Secondary outcome [5]
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Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
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Assessment method [5]
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Bone marrow MRD status is defined as positive with \>= 0.1 detectable leukemia cells.
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Timepoint [5]
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5 years
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Secondary outcome [6]
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Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
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Assessment method [6]
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Bone marrow MRD status is defined as negative with \< 0.1 detectable leukemia cells.
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Timepoint [6]
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5 years
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Eligibility
Key inclusion criteria
* Must be eligible for and enrolled on classification study COG-AALL03B1
* Newly diagnosed B-precursor acute lymphoblastic leukemia
* WBC > 50,000/mm^3 for patients age 1 to 9
* Any WBC for patients age 10 to 30 OR patients who have received prior steroid therapy OR patients with testicular disease
* Whit blood cell (WBC) criteria:
* Age 1 - 9 years: WBC >= 50,000/uL
* Age 10 - 30 years: any WBC
* Prior steroid therapy: any WBC
* Testicular disease: any WBC
* Patients shall have had no other prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine
* Patients receiving prior steroid therapy (as described in AALL03B1) are eligible for study; the dose and duration of previous steroid therapy should be carefully documented
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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Minimum age
1
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Maximum age
30
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients with Down syndrome are ineligible to enroll onto this study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/12/2003
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
31/03/2021
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Sample size
Target
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Accrual to date
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Final
3154
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Women's and Children's Hospital-Adelaide - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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4029 - Herston
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5006 - North Adelaide
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3052 - Parkville
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Recruitment postcode(s) [4]
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6008 - Perth
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Recruitment outside Australia
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
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Trial website
https://clinicaltrials.gov/study/NCT00075725
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Trial related presentations / publications
Advani AS, Larsen E, Laumann K, Luger SM, Liedtke M, Devidas M, Chen Z, Yin J, Foster MC, Claxton D, Coffan K, Tallman MS, Appelbaum FR, Erba H, Stone RM, Hunger SP, McNeer JL, Loh ML, Raetz E, Winick N, Carroll W, Larson RA, Stock W. Comparison of CALGB 10403 (Alliance) and COG AALL0232 toxicity results in young adults with acute lymphoblastic leukemia. Blood Adv. 2021 Jan 26;5(2):504-512. doi: 10.1182/bloodadvances.2020002439. Wood B, Wu D, Crossley B, Dai Y, Williamson D, Gawad C, Borowitz MJ, Devidas M, Maloney KW, Larsen E, Winick N, Raetz E, Carroll WL, Hunger SP, Loh ML, Robins H, Kirsch I. Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL. Blood. 2018 Mar 22;131(12):1350-1359. doi: 10.1182/blood-2017-09-806521. Epub 2017 Dec 28. Karol SE, Mattano LA Jr, Yang W, Maloney KW, Smith C, Liu C, Ramsey LB, Fernandez CA, Chang TY, Neale G, Cheng C, Mardis E, Fulton R, Scheet P, San Lucas FA, Larsen EC, Loh ML, Raetz EA, Hunger SP, Devidas M, Relling MV. Genetic risk factors for the development of osteonecrosis in children under age 10 treated for acute lymphoblastic leukemia. Blood. 2016 Feb 4;127(5):558-64. doi: 10.1182/blood-2015-10-673848. Epub 2015 Nov 20. Karol SE, Yang W, Van Driest SL, Chang TY, Kaste S, Bowton E, Basford M, Bastarache L, Roden DM, Denny JC, Larsen E, Winick N, Carroll WL, Cheng C, Pei D, Fernandez CA, Liu C, Smith C, Loh ML, Raetz EA, Hunger SP, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Mattano LA Jr, Relling MV. Genetics of glucocorticoid-associated osteonecrosis in children with acute lymphoblastic leukemia. Blood. 2015 Oct 8;126(15):1770-6. doi: 10.1182/blood-2015-05-643601. Epub 2015 Aug 11. Borowitz MJ, Wood BL, Devidas M, Loh ML, Raetz EA, Salzer WL, Nachman JB, Carroll AJ, Heerema NA, Gastier-Foster JM, Willman CL, Dai Y, Winick NJ, Hunger SP, Carroll WL, Larsen E. Prognostic significance of minimal residual disease in high risk B-ALL: a report from Children's Oncology Group study AALL0232. Blood. 2015 Aug 20;126(8):964-71. doi: 10.1182/blood-2015-03-633685. Epub 2015 Jun 29. Fernandez CA, Smith C, Yang W, Date M, Bashford D, Larsen E, Bowman WP, Liu C, Ramsey LB, Chang T, Turner V, Loh ML, Raetz EA, Winick NJ, Hunger SP, Carroll WL, Onengut-Gumuscu S, Chen WM, Concannon P, Rich SS, Scheet P, Jeha S, Pui CH, Evans WE, Devidas M, Relling MV. HLA-DRB1*07:01 is associated with a higher risk of asparaginase allergies. Blood. 2014 Aug 21;124(8):1266-76. doi: 10.1182/blood-2014-03-563742. Epub 2014 Jun 26.
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Public notes
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Contacts
Principal investigator
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Eric C Larsen
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Children's Oncology Group
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00075725
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