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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00304005
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following hematologic malignancies:
* Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)
* CLL in transformation allowed
* Richter syndrome
* Other refractory lymphoproliferative diseases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Creatinine ≤ 2.0 mg/dL
* Renal dysfunction due to organ infiltration by disease allowed
* AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
* Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No symptomatic coronary artery disease
* No arrhythmia not controlled by medication
* No uncontrolled, symptomatic congestive heart failure
* No myocardial infarction within the past 3 months
* No other uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
* At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
* No other concurrent standard or investigational treatment for this cancer
* No other concurrent cytotoxic investigational drugs
* No concurrent disulfiram
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00304005
Study Brief:
Protocol Section:
NCT00304005