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

Sponsor:	Immunomedics, Inc.
Information provided by:	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00061425

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Epratuzumab Yttrium Y 90 Epratuzumab

U.S. FDA Resources

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

Study ID Numbers:	IM-T-hLL2-06-EU
Study First Received:	May 27, 2003
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00061425 History of Changes
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, B-Cell
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 22, 2009