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NCT00408005 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,895
- Enrollment target
NCT00408005: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00408005 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,895 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00408005, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,895 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
Primary Outcome
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
- DRUG Asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,895 participants |
| Start Date | 2007-01-30 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 3 |
What the finished NCT00408005 record still lists
NCT00408005 is an interventional study that assigns participants to a tested intervention. Its 1,895 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 (145% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00408005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00408005 about?
NCT00408005 is a clinical study titled "Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma". This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in dif...
What is the current status of trial NCT00408005?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,895 participants. The study started on 2007-01-30. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT00408005?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG), Asparaginase (DRUG).
Who is sponsoring clinical trial NCT00408005?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00408005's enrollment target sits among peer trials
1,895 113th of 2000 higher than 1,888 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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