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NCT00981799 · ClinicalTrials.gov registry record · Phase 1
Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Terminated
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00981799: Clinical Trial Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT00981799 is a Phase 1 study that was terminated before completion, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00981799, a Phase 1 study, was terminated before completion, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
Primary Outcome
Patients will be evaluated based on Dose Level and total courses taken at each dose level and for presence of dose limiting toxicities. Not all patients enrolled at each dose level has been assessed to be evaluable for DLTs. Only those that have met criteria for being evaluable for DLT will be counted in the Overall Number of Participants Analyzed.
Interventions
- DRUG Cyclophosphamide
- DRUG Etoposide
- DRUG Methotrexate
- DRUG Filgrastim
- DRUG Nelarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-06 |
| Est. Completion | 2016-07-18 |
| Phase | Phase 1 |
Why NCT00981799 stopped before completion
NCT00981799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00981799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00981799 about?
NCT00981799 is a clinical study titled "Trial of Nelarabine, Etoposide and Cyclophosphamide in Relapsed T-cell ALL and T-cell LL". Nelarabine has shown significant activity in patients with T-cell malignancies. This study will determine the safety and maximum tolerated dose of the combination of nelarabine, cyclophosphamide and etoposide in patients with first bone marrow relapse of T-ALL, or first relapse of T-LL.
What is the current status of trial NCT00981799?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-06. Estimated completion is 2016-07-18.
What interventions are being tested in trial NCT00981799?
The interventions under investigation include: Cyclophosphamide (DRUG), Etoposide (DRUG), Methotrexate (DRUG), Filgrastim (DRUG), Nelarabine (DRUG).
Who is sponsoring clinical trial NCT00981799?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00981799's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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