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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00005619

Enrollment

Registered

2004-07-19

Start date

2000-02-29

Completion date

2001-08-31

Last updated

2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

progressive hairy cell leukemia, initial treatment, refractory hairy cell leukemia

Brief 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.

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.

Interventions

GENETICpolymerase chain reaction

OTHERflow cytometry

OTHERimmunohistochemistry staining method

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026