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NCT00075725 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,154
- Enrollment target
NCT00075725: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00075725 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 3,154 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (309% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00075725, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,154 participants
- Enrollment target
Study 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.
Primary Outcome
Event Free Probability.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,154 participants |
| Start Date | 2003-12-29 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 3 |
What the finished NCT00075725 record still lists
NCT00075725 is an interventional study that assigns participants to a tested intervention. Its 3,154 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (309% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00075725 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00075725 about?
NCT00075725 is a clinical study titled "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". 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...
What is the current status of trial NCT00075725?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,154 participants. The study started on 2003-12-29. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT00075725?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00075725?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00075725's enrollment target sits among peer trials
3,154 75th of 2000 higher than 1,926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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