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

Gilead Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Leukemia, B-Cell, Chronic; Lymphoma, Low-Grade; Lymphoma, Mixed-Cell; Lymphoma, Lymphoplasmacytoid, CLL; Lymphoplasmacytoid Lymphoma, CLL; Lymphoma, Small-Cell; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; CLL; NHL; Lymphoma, Follicular; Lymphoma, Large-Cell; SLL; Lymphoma, Small Lymphocytic; Lymphoma, Intermediate-Grade; Leukemia, Small Lymphocytic; Leukemia, Prolymphocytic; Leukemia, Lymphocytic, Chronic

Treatments: Biological: veltuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546793

IM-T-hA20-08

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL)
• Either previously untreated or relapsed
• Measurable disease (at least one lesion > 1.5 cm for NHL, or ALC > 5,000 for CLL) see full protocol for additional criteria

Exclusion criteria

• Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
• Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).

see full protocol for additional criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

veltuzumab

Experimental group

Description:

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

Treatment:

Biological: veltuzumab