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NCT00860457 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00860457: Completed Phase 2 study, sponsored by Georgetown University.
NCT00860457 is a Phase 2 study that has completed, run by Georgetown University. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00860457, a Phase 2 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease. Current therapy for this disease includes the use of combination chemotherapy regimens containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this research because we are attempting to improve the response, or outcome, of Fludarabine and Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. This research is being done because we are attempting to find a better treatment for chronic lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of Fludarabine and Rituximab. The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and Rituximab alone.
Primary Outcome
Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be \< 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocell
Interventions
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00860457 record still lists
NCT00860457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Fludarabine is the first listed.
NCT00860457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00860457 about?
NCT00860457 is a clinical study titled "Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)". This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received any treatment for their disease. Current therapy for this disease includes the use of combination chemotherapy regimens containing Fludarabine and Rituximab, which have been found to be very effective for C...
What is the current status of trial NCT00860457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2008-02. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00860457?
The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00860457?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00860457's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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