Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00412594
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older
* Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination
* Patients with relapsed disease are eligible if they have had no more than one prior therapy
* Women of child-bearing potential must use birth control (oral contraceptive, barrier, abstinence or any other acceptable method) for the duration of the study
* Performance status =\< 3
* Creatinine less than or equal to 2.0 unless related to the disease
* Bilirubin less than or equal to 3.0
* Transaminases less than or equal 3 x upper limit of normal unless related to the disease
* No prior investigational agent in the 4 weeks prior to initiation of therapy
Exclusion Criteria:
* Unable or unwilling to sign the consent form
* Known infection with human immunodeficiency virus (HIV), hepatitis B or C
* Presence of active infection
* Presence of central nervous system (CNS) metastases
* New York Heart Association classification III or IV heart disease
* Prior chemotherapy (last 4 weeks)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00412594
Study Brief:
Protocol Section:
NCT00412594