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NCT00509600 · ClinicalTrials.gov registry record · Phase 2
Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00509600: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00509600 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00509600, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Primary Objectives: 1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML. 1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JMML) \[mutations in NF1, Ras, SHP2\] or levels of TNFa. 1.3 Determine if TNF blockade by etanercept results in inhibition of free levels of TNFa and other cytokines by ELISA and bioassay and improves blood counts. 1.4 Estimate the two year event free survival and overall survival in JMML patients following etanercept and allogeneic hematopoietic stem cell transplantation.
Primary Outcome
Response is defined as a WBC \< 15,000 and platelets \> 75,000 at 12 weeks; toxicity is defined as a grade 3 or worse infection or non-hematologic toxicity within the first 4 weeks.
Interventions
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
Why NCT00509600 stopped before completion
NCT00509600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Etanercept is the first listed.
NCT00509600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00509600 about?
NCT00509600 is a clinical study titled "Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia". Primary Objectives: 1.1 Estimate rate of response and define acute toxicity to etanercept used in an up-front phase II window in newly diagnosed or relapsed JMML. 1.2 Determine if response to Tumor Necrosis Factor (TNF) blockade correlates with genetic basis of Juvenile Myelomonocytic Leukemia (JM...
What is the current status of trial NCT00509600?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2004-09. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00509600?
The interventions under investigation include: Etanercept (DRUG).
Who is sponsoring clinical trial NCT00509600?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00509600's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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