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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Biological: veltuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: veltuzumab<br>veltuzumab is a humanized CD20 antibody administered subcutaneously in this study. | Biological: veltuzumab<br>* veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.<br>* Other names: IMMU-106;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability | safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years. | over 2 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously