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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	24 August 2021
Main ID:	NCT00003337
Date of registration:	01/11/1999
Prospective Registration:	No
Primary sponsor:	Gilead Sciences
Public title:	Radiolabeled Monoclonal Antibody in the Detection and Staging of Patients With Non-Hodgkin's Lymphoma
Scientific title:	The Utility of LymphoScan Imaging in the Localization and Staging of Patients With Non-Hodgkin's Lymphoma
Date of first enrolment:	March 1997
Target sample size:	100
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT00003337
Study type:	Interventional
Study design:	Primary purpose: Diagnostic.
Phase:	Phase 3

Countries of recruitment
Austria	Italy	Sweden	Switzerland	United States

Contacts

Name:	William A. Wegener, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Gilead Sciences

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed B-cell non-Hodgkin's lymphoma (low,
intermediate, or high grade categories) A new classification scheme for adult non-Hodgkin's
lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma
will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: BUN no greater than
1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN Other: No
known allergies to mouse proteins No second primary malignancy within past 5 years other
than adequately treated in situ carcinoma of the cervix or uterus, or basal or squamous
cell carcinoma of the skin Not pregnant or nursing Effective contraception required of all
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior exposure to mouse antibodies other
than technetium Tc 99m LL2 monoclonal antibody Chemotherapy: Not specified Endocrine
therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 1
month since any other prior investigational therapy No concurrent participation in another
protocol involving medical devices or investigational agents

Age minimum: 16 Years
Age maximum: 120 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoma

Intervention(s)

Procedure: immunoscintigraphy

Radiation: technetium Tc 99m epratuzumab

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

NCI-V98-1417

CDR0000066308

IM-D-LL2-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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