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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

NHL CLL Chronic Disease Dendritic Cell Sarcoma, Interdigitating Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, B-Cell, Chronic Leukemia, Lymphocytic, Chronic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Leukemia, Small Lymphocytic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Intermediate-Grade Lymphoma, Large-Cell Lymphoma, Low-Grade Lymphoma, Lymphoplasmacytoid, CLL Lymphoma, Mixed-Cell Lymphoma, Non-Hodgkin Lymphoma, Small Lymphocytic Lymphoma, Small-Cell Lymphoplasmacytoid Lymphoma, CLL Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms SLL

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lewis Cancer Center and Research Pavilion, Savannah, Georgia, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

veltuzumab

Biological

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

Other names: hA20, humanized anti-CD20, IMMU-106

Primary outcomes

Safety/tolerability

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Oct 19, 2007
Registry last updated: Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed