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NCT00078234 · ClinicalTrials.gov registry record · Phase 1
Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia
A Phase 1 study, sponsored by Genta Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00078234: Completed Phase 1 study, sponsored by Genta Incorporated.
NCT00078234 is a Phase 1 study that has completed, run by Genta Incorporated. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00078234, a Phase 1 study, has completed, sponsored by Genta Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.
Interventions
- DRUG Oblimersen-rituximab-fludarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2003-11 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT00078234 record still lists
NCT00078234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Oblimersen-rituximab-fludarabine is the first listed.
NCT00078234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00078234 about?
NCT00078234 is a clinical study titled "Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia". The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer dr...
What is the current status of trial NCT00078234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2003-11. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00078234?
The interventions under investigation include: Oblimersen-rituximab-fludarabine (DRUG).
Who is sponsoring clinical trial NCT00078234?
This trial is sponsored by Genta Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00078234's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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