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:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00005619
First received: May 2, 2000
Last updated: February 18, 2011
Last verified: February 2011
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005619

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

Additional Information:
No publications provided

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
Study First Received: May 2, 2000
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 19, 2014