Trials / Completed
CompletedNCT00546793
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | veltuzumab | veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks. |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2007-10-19
- Last updated
- 2021-08-16
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00546793. Inclusion in this directory is not an endorsement.