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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005619 |
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: | Interventional |
| Study Design: | Diagnostic |
| Official Title: | Detection of Hairy Cell Leukemia Minimal Residual Disease: Detection by Flow Cytometry |
| Study Start Date: | February 2000 |
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 |
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| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Loann C. Peterson, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000067759, NU-97Z3, NCI-G00-1754 |
| Study First Received: | May 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005619 History of Changes |
| Health Authority: | United States: Federal Government |
|
progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia |
|
Neoplasm, Residual Lymphatic Diseases Leukemia Leukemia, Hairy Cell |
Immunoproliferative Disorders Hairy Cell Leukemia Lymphoproliferative Disorders |
|
Neoplasm, Residual Lymphatic Diseases Leukemia Neoplastic Processes Neoplasms Leukemia, Hairy Cell |
Pathologic Processes Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Lymphoproliferative Disorders |
