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NCT00535873 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT00535873: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00535873 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00535873, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
Primary Objective: * To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older. Secondary Objective: * To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older
Primary Outcome
ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes \>1500/µL, platelets \>100,000/µL, hemoglobin \>11.0 g/dL (untransfused); lymphocyte count \<5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with \<30% of nucleated cells
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT00535873 record still lists
NCT00535873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT00535873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00535873 about?
NCT00535873 is a clinical study titled "Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older". Primary Objective: * To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older. Secondary Objective: * To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older
What is the current status of trial NCT00535873?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2007-10. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00535873?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00535873?
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 NCT00535873's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 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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