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COMPLETED Phase 2

Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT01113632 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 77 participants
Start Date 2010-07
Est. Completion 2016-08
Phase Phase 2

Sponsor

SCRI Development Innovations

63 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01113632 reports 13 study locations spanning 10 distinct geographic areas — top geographies include Florida, Ohio, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01113632?

The interventions under investigation include: Ofatumumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01113632?

This trial is sponsored by SCRI Development Innovations, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial