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NCT00974233 · ClinicalTrials.gov registry record · Phase 2
Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 10
- Study locations
NCT00974233: Completed Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by University of Wisconsin, Madison.
NCT00974233 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 34 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (81% lower). The trial reports 10 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00974233, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
Primary Outcome
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Bendamustine
Study Locations (10)
Wisconsin
- St Vincent Regional Cancer Center - Green Bay
- Bellin Memorial Hospital - Green Bay
- Mercy Health System Heme/Onc - Janesville
- Gundersen Clinic - La Crosse
- University of Wisconsin Carbone Cancer Center - Madison
- Marshfield Clinic - Marshfield
- Medical College of Wisconsin - Milwaukee
- Oconomowoc Memorial Hospital - Oconomowoc
- Waukesha Memorial Hospital - Waukesha
- Riverview Hospital - Wisconsin Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT00974233 record still lists
NCT00974233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT00974233 lists 10 locations in 1 state (Wisconsin).
Frequently Asked Questions
What is clinical trial NCT00974233 about?
NCT00974233 is a clinical study titled "Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL". The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is t...
What is the current status of trial NCT00974233?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2009-10. Estimated completion is 2015-04.
What conditions does trial NCT00974233 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT00974233?
The interventions under investigation include: Rituximab (DRUG), Lenalidomide (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT00974233?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00974233 being conducted?
This trial has 10 study locations across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00974233's enrollment target sits among peer trials
34 125th of 187 higher than 61 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.
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