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

This study has been completed.
Sponsor:
Information provided by:
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00061425
First received: May 27, 2003
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Lymphoma, B-Cell
Drug: radiolabeled epratuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG

Resource links provided by NLM:


Further study details as provided by Immunomedics, Inc.:

Study Start Date: August 2000
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061425

Sponsors and Collaborators
Immunomedics, Inc.
Investigators
Study Director: William Wegener Immunomedics, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00061425     History of Changes
Other Study ID Numbers: IM-T-hLL2-06-EU
Study First Received: May 27, 2003
Last Updated: January 8, 2009
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (Paul Erlich Institute)

Keywords provided by Immunomedics, Inc.:
NHL
recurrent B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 14, 2014