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Veltuzumab

veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.

veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.

veltuzumab

William Wegener, MD, PhD

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.

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

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

safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

Gilead Sciences

Shock

Lymphoma, B-Cell, Marginal Zone

Marginal Zone Lymphoma

Vaccines

Immunomodulating Agents

autologous human tumor-derived HSPPC-96

Primary Objectives:

* To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
* the rate of complete and partial responses
* the time to progression.

Secondary Objectives:

* To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
* To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
* To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
* To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.

A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)

Agenus Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL	NCT00546793	NHL Lymphoma, Non-H... Lymphoma, B-Cel... Lymphoma, Folli... Lymphoma, Inter... Lymphoma, Large... Lymphoma, Low-G... Lymphoma, Mixed... Lymphoma, Small... Leukemia, Lymph... Leukemia, B-Cel... Leukemia, Proly... Leukemia, Small... Lymphoma, Small... Lymphoma, Lymph... Lymphoplasmacyt... CLL SLL	veltuzumab	18 Years -	Gilead Sciences
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma	NCT00081809	Lymphoma, Folli... Lymphoma, Small...	autologous huma...	-	Agenus Inc.

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