Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia MedDRA version: 9.1 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma MedDRA version: 9.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia
Conditions
Interventions
Product Name: veltuzumab
Product Code: IMMU-106
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: veltuzumab
CAS Number: 728917-18-8
Current Sponsor code: IMMU-106
Other
Sponsors
Immunomedics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: histologically confirmed diagnosis of CD20+ follicular, small lymphocytic lymphoma or marginal zone NHL or CLL; either previously untreated or relapsed; male or female, age 18 years or older; adequate performance status with an estimated life expectancy of at least 6 months; patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after last infusion; women of childbearing potential must have a negative urine or serum pregnancy test; sign EC-approved informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: previously untreated NHL patient with Stage I and II disease; previously untreated CLL patients with Stage 0-2 disease unless specific treatment indications by NCCN guidelines exist; relapsed patients receiving more than 4 prior treatment regimens; known central nervous system involvement by lymphoma, HIV lymphoma, transformed lymphoma; prior malignancies unless disease free for 5 years; rituximab resistant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if a subcutaneous dosing schedule of veltuzumab can be established in NHL or CLL paitent and to confirm safety and efficacy of veltuzumab that was previously established when administered intravenously.;Secondary Objective: To document the safety, tolerance and lack of immunogenicity of veltuzumab with this route of administration and to assess pharmacodynamics, pharmacokinetics, and to document evidence of efficacy in these patient groups;Primary end point(s): Efficacy endpoints will be evaluated using CT-based International Working Group (Cheson) criteria for NHL patients and hematolgoy based NCI criteria for CLL patients; Safety evaluations include monitoring for injection reactions or other adverse events, vital signs, physical examination, and safety laboratories, including hematology, T-cell levels, serum immunoglobulins, etc. Immunogenicity will be evaluated from serum samples; Pharmacodynamics will be evaluated from changes in circulating B-cell levels from baseline values; Pharmacokinetics will be evaluated from serum samples | — |
Countries
France
Outcome results
None listed