Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Public ClinicalTrials.gov record NCT01113632. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II Trial of Ofatumumab for Older Patients and Patients Who Refuse Fludarabine-Based Regimens With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01113632
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 77 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2010
- Primary completion
- Feb 28, 2015
- Completion
- Jul 31, 2016
- Last update posted
- Sep 19, 2016
2010 – 2016
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Robles | Thousand Oaks | California | 91360 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 34236 | — |
| Woodlands Medical Specialists | Pensacola | Florida | 32503 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Providence Medical Group | Terre Haute | Indiana | 47802 | — |
| St. Louis Cancer Care | Chesterfield | Missouri | 63017 | — |
| Portsmouth Regional Hospital | Portsmouth | New Hampshire | 03801 | — |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07960 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | — |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01113632, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 19, 2016 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01113632 live on ClinicalTrials.gov.