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

Tracking Information

First Received Date ^ICMJE

May 27, 2003

Last Updated Date

January 8, 2009

Start Date ^ICMJE

August 2000

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00061425 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Dose Comparison
Endpoint Classification:  Safety Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Non-Hodgkin's Lymphoma
Lymphoma, B-Cell

Intervention ^ICMJE

Drug: radiolabeled epratuzumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00061425

Responsible Party

Study ID Numbers ^ICMJE

IM-T-hLL2-06-EU

Study Sponsor ^ICMJE

Immunomedics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

William Wegener

Immunomedics, Inc.

Information Provided By

Immunomedics, Inc.

Verification Date

January 2009

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