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NCT01113632 · ClinicalTrials.gov registry record · Phase 2
Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
- 13
- Study locations
NCT01113632 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that has completed, run by SCRI Development Innovations. The registered enrollment target is 77 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (57% lower). The trial reports 13 study locations across 10 states.
The verdict
NCT01113632, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
- 13
- Study locations
Study Summary
The risk of immunosuppression deters many patients from receiving fludarabine, while combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that rituximab is safe and well tolerated when used as a single agent in patients with CLL. In addition, maintenance therapy with rituximab was well tolerated by CLL patients, with probable prolongation of progression-free survival (Hainsworth et al. 2003). Based on pre clinical and clinical studies indicating possible increased efficacy of ofatumumab in patients with CLL, we wish to develop an antibody-only regimen for older patients and patients who refuse fludarabine-based regimens.
Conditions Studied
Interventions
- DRUG Ofatumumab
Study Locations (13)
Florida
- Florida Cancer Specialists - Fort Myers
- Woodlands Medical Specialists - Pensacola
Ohio
- Oncology Hematology Care - Cincinnati
- The Ohio State University - Columbus
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Tennessee Oncology - Nashville
California
- Los Robles - Thousand Oaks
Georgia
- Northeast Georgia Medical Center - Gainesville
Indiana
- Providence Medical Group - Terre Haute
Missouri
- St. Louis Cancer Care - Chesterfield
New Hampshire
- Portsmouth Regional Hospital - Portsmouth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2010-07 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01113632
The ClinicalTrials.gov registry entry for NCT01113632 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (57% lower). The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Ofatumumab is the first listed.
NCT01113632 reports 13 study locations spanning 10 distinct geographic areas - top geographies include Florida, Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT01113632 about?
NCT01113632 is a clinical study titled "Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". The risk of immunosuppression deters many patients from receiving fludarabine, while combination chemotherapy regimens are poorly tolerated by elderly or infirm chronic lymphocytic leukemia (CLL) patients. Previous studies by our group and others have shown that rituximab is safe and well tolerated ...
What is the current status of trial NCT01113632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2010-07. Estimated completion is 2016-08.
What conditions does trial NCT01113632 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT01113632?
The interventions under investigation include: Ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01113632?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01113632 being conducted?
This trial has 13 study locations across California, Florida, Georgia, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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