ICTRP Search Portal

Main

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:	NCT00003338
Date of registration:	01/11/1999
Prospective Registration:	No
Primary sponsor:	Gilead Sciences
Public title:	Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma
Scientific title:	The Utility of LymphoScan Imaging in the Dectection of Residual Tumor After Chemotherapy and/or Radiotherapy in Patients With Non-Hodgkin's Lymphoma
Date of first enrolment:	March 1997
Target sample size:	60
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT00003338
Study type:	Interventional
Study design:	Primary purpose: Diagnostic.
Phase:	Phase 2/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) Must have been treated with chemotherapy and/or
radiotherapy with evidence of minimal residual disease by conventional diagnostic
modalities 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 LymphoScan Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics 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)

Radiation: technetium Tc 99m epratuzumab

Procedure: immunoscintigraphy

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

CDR0000066309

IM-D-LL2-06

NCI-V98-1418

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:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.