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NCT00536341 · ClinicalTrials.gov registry record · Phase 1
Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 6
- Study locations
NCT00536341: Completed Phase 1 study of Chronic Lymphocytic Leukemia, sponsored by SCRI Development Innovations.
NCT00536341 is a Phase 1 study of Chronic Lymphocytic Leukemia that has completed, run by SCRI Development Innovations. The registered enrollment target is 64 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (65% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00536341, a Phase 1 study of Chronic Lymphocytic Leukemia, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known, this trial will perform a phase I component followed by a phase II examination to further explore this regimen's activity.
Primary Outcome
Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Rituximab
- DRUG lenalidomide
Study Locations (6)
Florida
- Florida Cancer Specialists - Fort Myers
- Florida Hospital Cancer Institute - Orlando
Maryland
- Center for Cancer and Blood Disorders - Bethesda
- National Capital Clinical Research Consortium - Bethesda
South Carolina
- South Carolina Oncology Associates, PA - Columbia
Tennessee
- Tennessee Oncology, PLLC - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2008-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT00536341 record still lists
NCT00536341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Fludarabine is the first listed.
NCT00536341 lists 6 locations in 4 states (Florida, Maryland, South Carolina).
Frequently Asked Questions
What is clinical trial NCT00536341 about?
NCT00536341 is a clinical study titled "Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)". This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin Oncol 23(18):4079-88, 2005)...
What is the current status of trial NCT00536341?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2008-01. Estimated completion is 2016-11.
What conditions does trial NCT00536341 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT00536341?
The interventions under investigation include: Fludarabine (DRUG), Rituximab (DRUG), lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00536341?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00536341 being conducted?
This trial has 6 study locations across Florida, Maryland, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00536341's enrollment target sits among peer trials
64 83rd of 187 higher than 103 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia 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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