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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-000434-47-FR |
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Date of registration:
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28/02/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia
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Scientific title:
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A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia |
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Date of first enrolment:
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22/07/2008 |
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Target sample size:
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46 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000434-47 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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France
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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:
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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 descriptive name: hA20
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.2 mL-
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Primary Outcome(s)
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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
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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
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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.
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Secondary ID(s)
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IM-T-hA20-08
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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