Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Genta Incorporated. The registered enrollment target is 25 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078234
The ClinicalTrials.gov registry entry for NCT00078234 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genta Incorporated, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oblimersen-rituximab-fludarabine is the first listed.
NCT00078234 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.