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Clinical Trials/EUCTR2008-000434-47-FR
EUCTR2008-000434-47-FR
Active, not recruiting
Not Applicable

A Phase I/II Study of Immunotherapy with Subcutaneous Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lyphocytic Leukemia

Immunomedics, Inc.0 sites46 target enrollmentFebruary 28, 2008
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Immunomedics, Inc.
Enrollment
46
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 28, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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