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NCT00549848 · ClinicalTrials.gov registry record · Phase 3
Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
A Phase 3 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
NCT00549848 is a Phase 3 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 600 participants.
The verdict
NCT00549848, a Phase 3 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
Study Summary
The primary objective of this study (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. This study has several secondary objectives: Therapeutic Objectives: To estimate the event-free survival and overall survival of children with ALL who are treated with risk-directed therapy. To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD \> 5%, will result in improved leukemia cytoreduction in this subgroup compared to TOTXV. To assess whether intensification of central nervous system (CNS)-directed intrathecal and systemic chemotherapy will improve outcome in patients at high risk of CNS relapse. Exploratory Pharmacologic Objectives: To identify pharmacogenetic, pharmacokinetic and pharmacodynamic predictors for treatment-related outcomes in the context of the systemic therapy used in the protocol. To compare the pharmacokinetics and pharmacodynamics of PEG-asparaginase given in higher dose (3,500 or 3,000 units/m2) versus those of PEG-asparaginase given in conventional dose (2,500 units/m2) in the continuation phase. Exploratory Biologic Objectives: To determine the prognostic value of levels of minimal residual disease in peripheral blood at day 8 of remission induction. To validate new markers and methods for MRD detection. To genotype natural killer (NK) cell receptors and measure their expressions at diagnosis and before reinduction, and to associate these features with treatment outcome. To identify new prognostic factors by applying new technologies to study patient material (e.g., stored plasma, serum, cerebrospinal fluid, and normal and leukemic cells). Exploratory Neuroimaging Objectives: To use quantitative MR measures (Diffusion Tensor Imaging and high reso
Interventions
- DRUG Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine
- DRUG Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2007-10-29 |
| Est. Completion | 2022-03-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00549848
The ClinicalTrials.gov registry entry for NCT00549848 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine is the first listed.
NCT00549848 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00549848 about?
NCT00549848 is a clinical study titled "Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia". The primary objective of this study (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 continuat...
What is the current status of trial NCT00549848?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2007-10-29. Estimated completion is 2022-03-26.
What interventions are being tested in trial NCT00549848?
The interventions under investigation include: Prednisone, Vincristine, Daunorubicin, PEG-L-asparaginase, Erwinia L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Thioguanine (DRUG), Clofarabine, Methotrexate, Mercaptopurine, Dexamethasone, Etoposide, Dasatinib (DRUG).
Who is sponsoring clinical trial NCT00549848?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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