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Analysis of Blood and Bone Marrow to Detect Residual Disease in Patients With Previously Treated Hairy Cell Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005619
First Posted: July 19, 2004
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Northwestern University
  Purpose

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.


Condition Intervention
Leukemia Genetic: polymerase chain reaction Other: flow cytometry Other: immunohistochemistry staining method

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Hairy Cell Leukemia Minimal Residual Disease: Detection by Flow Cytometry

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Enrollment: 16
Study Start Date: February 2000
Study Completion Date: August 2001
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a documented diagnosis of hairy cell leukemia who are undergoing routine bone marrow boipsy/aspiration and peripheral blood collection.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005619


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: Loann C. Peterson, MD Robert H. Lurie Cancer Center
  More Information

Responsible Party: LoAnn Peterson, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00005619     History of Changes
Other Study ID Numbers: NU 97Z3
NU-97Z3
NCI-G00-1754
First Submitted: May 2, 2000
First Posted: July 19, 2004
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by Northwestern University:
progressive hairy cell leukemia, initial treatment
refractory hairy cell leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases