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NCT00038415 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00038415: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00038415 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00038415, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.
Interventions
- BIOLOGICAL CLL vaccine using DNA plasmid vector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2001-12 |
| Est. Completion | 2005-01 |
| Phase | Phase 1 |
Why NCT00038415 stopped before completion
NCT00038415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which CLL vaccine using DNA plasmid vector is the first listed.
NCT00038415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00038415 about?
NCT00038415 is a clinical study titled "A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach". The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a...
What is the current status of trial NCT00038415?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2001-12. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00038415?
The interventions under investigation include: CLL vaccine using DNA plasmid vector (BIOLOGICAL).
Who is sponsoring clinical trial NCT00038415?
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 NCT00038415's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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