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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms

  • CLL
  • Leukemia
  • Leukemia, B-Cell
  • Leukemia, B-Cell, Chronic
  • Leukemia, Lymphocytic, Chronic
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Prolymphocytic
  • Leukemia, Small Lymphocytic
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Follicular
  • Lymphoma, Intermediate-Grade
  • Lymphoma, Large-Cell
  • Lymphoma, Low-Grade
  • Lymphoma, Lymphoplasmacytoid, CLL
  • Lymphoma, Mixed-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Small Lymphocytic
  • Lymphoma, Small-Cell
  • Lymphoplasmacytoid Lymphoma, CLL
  • NHL
  • SLL
  • Waldenstrom Macroglobulinemia

NCT number NCT00546793
Study type Interventional
Source Gilead Sciences
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2008
Completion date March 2013

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