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Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Institutes of Health (NIH) |
Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00549848 |
The primary objective of TOTXVI is to compare the clinical benefit, the pharmacokinetics, and the pharmacodynamics of polyethylene glycol-conjugated (PEG) asparaginase given in higher dose(HD PEG) versus those of PEG-asparaginase given in conventional dose (CD PEG) during the continuation phase.
Condition | Intervention | Phase |
Acute Lymphoblastic Leukemia |
Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thiogunaine Drug: Clofarabine, Methotrexate, Mecaptopurine, Dexamethasone, Etoposide, Dasatinib |
Phase III |
MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia |
Estimated Enrollment: | 420 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | November 2019 |
Estimated Primary Completion Date: | November 2019 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
HD PEG |
Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thiogunaine
See Detailed Description section for details of treatment interventions.
Drug: Clofarabine, Methotrexate, Mecaptopurine, Dexamethasone, Etoposide, Dasatinib
See Detailed Description section for details of treatment interventions.
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CD PEG |
Drug: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thiogunaine
See Detailed Description section for details of treatment interventions.
Drug: Clofarabine, Methotrexate, Mecaptopurine, Dexamethasone, Etoposide, Dasatinib
See Detailed Description section for details of treatment interventions.
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Show Detailed Description |
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sima Jeha, MD | 1-866-278-5833 | info@stjude.org |
United States, Tennessee | |||||
St. Jude Children's Research Hospital | Recruiting | ||||
Memphis, Tennessee, United States, 38105 | |||||
Principal Investigator: Sima Jeha, MD |
St. Jude Children's Research Hospital |
National Institutes of Health (NIH) |
Principal Investigator: | Sima Jeha, MD | St. Jude Children's Research Hospital |
St. Jude Children's Research Hospital 
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Responsible Party: | St. Jude Children's Research Hospital ( Sima Jeha, MD / Principal Investigator ) |
Study ID Numbers: | TOTXVI |
First Received: | October 25, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00549848 |
Health Authority: | United States: Institutional Review Board |
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