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

Phase 1

Completed

• Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell; Leukemia, Lymphocytic, Chronic; Leukemia, Prolymphocytic; Lymphoplasmacytoid Lymphoma, CLL; Lymphoma, B-Cell; Lymphoma, Intermediate-Grade; Leukemia, B-Cell, Chronic; NHL; SLL
• Interventions: Biological: veltuzumab

• Registration Number: NCT00546793
• Lead Sponsor: Gilead Sciences

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

Study Timeline

• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-19
• Study Start: 2008-01
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Disposition First Submitted: 2021-08-12
• Disposition First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Disposition First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety/tolerability	over 2 years after treatment	safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

Trial Locations

Locations (5)

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Lewis Cancer Center and Research Pavilion; 🇺🇸 Savannah, Georgia, United States

Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A.; 🇺🇸 Denville, New Jersey, United States

Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

New York Hospital Weill Cornell Medical Center; 🇺🇸 New York, New York, United States