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NCT00413478 · ClinicalTrials.gov registry record · Phase 2
5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT00413478: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00413478 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00413478, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).
Primary Outcome
Overall response rate includes percentage of participants with complete response (CR) plus partial response (PR) responses using the National Cancer Institute (NCI) International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for response: Complete response defined as no palpable lymph nodes, liver or spleen and absence of symptoms. Neutrophil count \> 15,00/Mic L, and platelet count more than 100,000/MicL. Hemoglobin should be \> 11g/dl without transfusions. Lymphocyte count \<4000/m
Interventions
- DRUG 5-Azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
Why NCT00413478 stopped before completion
NCT00413478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-Azacytidine is the first listed.
NCT00413478 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00413478 about?
NCT00413478 is a clinical study titled "5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia". The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).
What is the current status of trial NCT00413478?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2006-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT00413478?
The interventions under investigation include: 5-Azacytidine (DRUG).
Who is sponsoring clinical trial NCT00413478?
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 NCT00413478's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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