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NCT01125176 · ClinicalTrials.gov registry record · Phase 2
Alternating Thalidomide and Lenalidomide Therapy Plus Rituximab (ThRiL) as Initial Treatment for Patients With CLL
A Phase 2 study of Chronic Lymphocytic Leukemia, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01125176 is a Phase 2 study of Chronic Lymphocytic Leukemia that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01125176, a Phase 2 study of Chronic Lymphocytic Leukemia, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators' hypothesis is that treatment of CLL with an alternating daily dosing schedule of thalidomide and lenalidomide may result in better tolerability by decreasing each agent's individual toxicities, while preserving efficacy, and therefore lead to a longer duration of therapy and improved responses. Additionally, the combination of the 2 agents may have additive or synergistic effects therapeutically. In Cycle -1, odd numbered patients will receive oral thalidomide daily days 1-14 followed by no treatment on days 15-28. Even numbered patients will receive oral lenalidomide daily on days 1-14 and then no treatment on days 15-28. Starting with cycle 1, patients will alternate daily thalidomide (every odd day) with daily lenalidomide (every even day) for days 1-28. Rituximab will be given on days 1, 8, 15, and 22 starting with Cycle 1, and then again every 6th cycle thereafter (cycles 7, 13, 19, etc.)
Conditions Studied
Interventions
- BIOLOGICAL rituximab
- DRUG lenalidomide
- DRUG thalidomide
Study Locations (1)
New York
- Weill Cornell Medical College - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2012-03-30 |
| Est. Completion | 2020-12-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01125176
The ClinicalTrials.gov registry entry for NCT01125176 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (92% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which rituximab is the first listed.
NCT01125176 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01125176 about?
NCT01125176 is a clinical study titled "Alternating Thalidomide and Lenalidomide Therapy Plus Rituximab (ThRiL) as Initial Treatment for Patients With CLL". The investigators' hypothesis is that treatment of CLL with an alternating daily dosing schedule of thalidomide and lenalidomide may result in better tolerability by decreasing each agent's individual toxicities, while preserving efficacy, and therefore lead to a longer duration of therapy and impro...
What is the current status of trial NCT01125176?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2012-03-30. Estimated completion is 2020-12-29.
What conditions does trial NCT01125176 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT01125176?
The interventions under investigation include: rituximab (BIOLOGICAL), lenalidomide (DRUG), thalidomide (DRUG).
Who is sponsoring clinical trial NCT01125176?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01125176 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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