Spots Global Cancer Trial Database for Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

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Trial Identification

Brief Title: Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

Official Title: Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Study ID: NCT00546793

Conditions

NHL

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Lymphoma, Follicular

Lymphoma, Intermediate-Grade

Leukemia, Lymphocytic, Chronic

Leukemia, B-Cell, Chronic

Leukemia, Prolymphocytic

Leukemia, Small Lymphocytic

Lymphoma, Small Lymphocytic

Lymphoma, Lymphoplasmacytoid, CLL

Lymphoplasmacytoid Lymphoma, CLL

CLL

SLL

Interventions

veltuzumab

Study Description

Brief 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