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NCT00096044 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 2 study of Leukemia, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT00096044: Completed Phase 2 study of Leukemia, sponsored by Roswell Park Cancer Institute.
NCT00096044 is a Phase 2 study of Leukemia that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 45 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096044, a Phase 2 study of Leukemia, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.
Primary Outcome
Percentage of patients achieving CR, PR or maintaining SD using the 1996 NCI-WF Criteria. CR: absence of lymph nodes and constitutional symptoms; no hepatomegaly or splenomegaly by physical examination; neutrophil count \>1500/μL; platelet count \>100,000/μL; untransfused hemoglobin concentration \>11.0g/dL; lymphocyte count \<4000/μL; bone marrow sample must be at least normocellular for age; with less than 30% of nucleated cells being lymphocytes and no lymphoid nodules. PR: ≥50% decrease in l
Conditions Studied
Interventions
- BIOLOGICAL rituximab
- DRUG lenalidomide
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2004-03 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT00096044 record still lists
NCT00096044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 2 interventions - of which rituximab is the first listed.
NCT00096044 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00096044 about?
NCT00096044 is a clinical study titled "Lenalidomide With or Without Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia". RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. C...
What is the current status of trial NCT00096044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2004-03. Estimated completion is 2015-06.
What conditions does trial NCT00096044 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00096044?
The interventions under investigation include: rituximab (BIOLOGICAL), lenalidomide (DRUG).
Who is sponsoring clinical trial NCT00096044?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00096044 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT00096044's enrollment target sits among peer trials
45 122nd of 233 higher than 109 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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