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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00005619
First received: May 2, 2000
Last updated: February 18, 2011
Last verified: February 2011
History of Changes

May 2, 2000
February 18, 2011
February 2000
August 2001   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00005619 on ClinicalTrials.gov Archive Site
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Analysis of Blood and Bone Marrow to Detect Residual Disease in Patients With Previously Treated Hairy Cell Leukemia
Detection of Hairy Cell Leukemia Minimal Residual Disease: Detection by Flow Cytometry

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with a documented diagnosis of hairy cell leukemia who are undergoing routine bone marrow boipsy/aspiration and peripheral blood collection.
Leukemia
  • Genetic: polymerase chain reaction
  • Other: flow cytometry
  • Other: immunohistochemistry staining method
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2001
August 2001   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005619
NU 97Z3, NU-97Z3, NCI-G00-1754
Not Provided
LoAnn Peterson, MD, Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Loann C. Peterson, MD Robert H. Lurie Cancer Center
Northwestern University
February 2011

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