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Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00061425
First Posted: May 28, 2003
Last Update Posted: January 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Immunomedics, Inc.
May 27, 2003
May 28, 2003
January 9, 2009
August 2000
November 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00061425 on ClinicalTrials.gov Archive Site
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Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG
Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG
The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Lymphoma, B-Cell
Drug: radiolabeled epratuzumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2007   (Final data collection date for primary outcome measure)

Inclusion:

  • Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.)
  • Measureable via CT, with at least one lesion > or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.)
  • Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.
  • Acceptable tumor burden that will allow adequate follow-up and evaluation.
  • Less that 25% bone marrow involvement, determined by bone marrow biopsy.
  • Must observe the following washout periods:

At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.

At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.

  • Must have Karnofsky score >70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months.
  • Serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min.
  • Serum bilirubin < or = 2mg/dl.
  • Hemoglobin > or = 10 g/dl; WBC > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
  • Immunomedics ELISA assay of HahLL2 < 100ng/ml for those with prior history of monoclonal antibody infusions.
  • Cognizant informed consent.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00061425
IM-T-hLL2-06-EU
No
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Immunomedics, Inc.
Not Provided
Study Director: William Wegener Immunomedics, Inc.
Immunomedics, Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP