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NCT01145495 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
A Phase 2 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT01145495: Completed Phase 2 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
NCT01145495 is a Phase 2 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, above the 47-participant average among 3 other Ann Arbor Stage III Grade 2 Follicular Lymphoma trials with a reported enrollment target (40% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01145495, a Phase 2 study of Ann Arbor Stage III Grade 2 Follicular Lymphoma and Ann Arbor Stage III Grade 3 Follicular Lymphoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide together with rituximab may kill more cancer cells.
Primary Outcome
Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- BIOLOGICAL Rituximab
Study Locations (20)
Illinois
- Saint Joseph Medical Center - Bloomington
- Illinois CancerCare-Bloomington - Bloomington
- Graham Hospital Association - Canton
- Illinois CancerCare-Canton - Canton
- Illinois CancerCare-Carthage - Carthage
- Memorial Hospital - Carthage
- University of Illinois - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- Heartland Cancer Research NCORP - Decatur
- Eureka Hospital - Eureka
- Illinois CancerCare-Eureka - Eureka
- Illinois CancerCare-Galesburg - Galesburg
- Illinois CancerCare-Havana - Havana
- Mason District Hospital - Havana
California
- Palo Alto Medical Foundation-Camino Division - Mountain View
- Palo Alto Medical Foundation Health Care - Palo Alto
Delaware
- Beebe Medical Center - Lewes
- Christiana Care Health System-Christiana Hospital - Newark
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- AdventHealth Orlando - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2010-06-15 |
| Est. Completion | 2022-01-15 |
| Phase | Phase 2 |
What the finished NCT01145495 record still lists
NCT01145495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 47-participant average among 3 other Ann Arbor Stage III Grade 2 Follicular Lymphoma trials with a reported enrollment target (40% higher).
The record links to 10 conditions, with Ann Arbor Stage III Grade 2 Follicular Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01145495 names 20 study sites across 5 states, led by Illinois, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT01145495 about?
NCT01145495 is a clinical study titled "Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma". This phase II trial studies how well lenalidomide and rituximab work in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop can...
What is the current status of trial NCT01145495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2010-06-15. Estimated completion is 2022-01-15.
What conditions does trial NCT01145495 study?
This clinical trial studies the following conditions: Ann Arbor Stage III Grade 2 Follicular Lymphoma, Ann Arbor Stage III Grade 3 Follicular Lymphoma, Ann Arbor Stage IV Grade 1 Follicular Lymphoma, Ann Arbor Stage III Grade 1 Follicular Lymphoma, Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma.
What interventions are being tested in trial NCT01145495?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01145495?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01145495 being conducted?
This trial has 20 study locations across California, Delaware, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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