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Auranofin

Auranofin 6 mg orally in the morning / 6 mg orally in the evening

6 mg twice a day for a total of 12 mg total daily dose

auranofin

Suman Kambhampati, MD

The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).

Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)

A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)

The Leukemia and Lymphoma Society

Kansas Bioscience Authority

Therapeutics for Rare and Neglected Diseases (TRND)

University of Kansas Medical Center

Heart and Blood Diseases

Lymphoma, Non-Hodgkin

Lymphoma, Follicular

Lymphoma, B-Cell

Waldenstrom Macroglobulinemia

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Immunoglobulins

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)	NCT01419691	Chronic Lymphoc... Small Lymphocyt... Leukemia, Proly...	auranofin	18 Years -	University of Kansas Medical Center
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

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