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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005619
Other study ID # NU 97Z3
Secondary ID NU-97Z3NCI-G00-1
Status Completed
Phase N/A
First received May 2, 2000
Last updated February 18, 2011
Start date February 2000
Est. completion date August 2001

Study information

Verified date February 2011
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Diagnostic procedures that detect residual disease may predict disease relapse in patients who have hairy cell leukemia.

PURPOSE: Diagnostic trial to determine the effectiveness of analyzing blood and bone marrow to detect residual disease in patients who have previously treated hairy cell leukemia.


Description:

OBJECTIVES: I. Compare the sensitivity of flow cytometry, immunohistochemistry, and polymerase chain reaction in detecting minimal residual disease following therapy with cladribine in patients with hairy cell leukemia.

OUTLINE: Blood and bone marrow samples are obtained from patients at time of bone marrow biopsies to assess minimal residual disease using flow cytometry, immunohistochemistry, and polymerase chain reaction. Patients are followed for 2 years or until disease relapse.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study over 12-24 months.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 2001
Est. primary completion date August 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS: Clinically documented hairy cell leukemia Active or in remission Must have received prior cladribine and be undergoing bone marrow biopsies as follow up

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy following prior cladribine Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Genetic:
polymerase chain reaction

Other:
flow cytometry

immunohistochemistry staining method


Locations

Country Name City State
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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