Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Completed · Phase 1/Phase 2
Conditions studied: NHL, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Intermediate-Grade, Lymphoma, Large-Cell, Lymphoma, Low-Grade, Lymphoma, Mixed-Cell, Lymphoma, Small-Cell, Leukemia, Lymphocytic, Chronic, Leukemia, B-Cell, Chronic, Leukemia, Prolymphocytic, Leukemia, Small Lymphocytic, Lymphoma, Small Lymphocytic, Lymphoma, Lymphoplasmacytoid, CLL, Lymphoplasmacytoid Lymphoma, CLL, CLL, SLL
In brief
The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.
Key facts
- Study ID
- NCT00546793
- Run by
- Gilead Sciences
- People needed
- 32
- Starts
- 2008-01-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2021-08-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL)
- Either previously untreated or relapsed
- Measurable disease (at least one lesion > 1.5 cm for NHL, or ALC > 5,000 for CLL) see full protocol for additional criteria
You may not qualify if…
- Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
- Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).
- see full protocol for additional criteria
Where it is running
- Lewis Cancer Center and Research Pavilion — Savannah, Georgia, United States
- Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A. — Denville, New Jersey, United States
- Morristown Memorial Hospital — Morristown, New Jersey, United States
- New York Hospital Weill Cornell Medical Center — New York, New York, United States
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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