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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: Completed Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by SCRI Development Innovations.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Number of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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 |
What the finished NCT01113632 record still lists
NCT01113632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (57% lower).
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 lists 13 locations in 10 states (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.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic 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 NCT01113632's enrollment target sits among peer trials
77 76th of 187 higher than 112 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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