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 @ 4:34 AM
Ignite Modification Date:
2025-12-25 @ 4:34 AM
NCT ID:
NCT00004218
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of B-cell chronic lymphocytic leukemia (CLL) requiring therapy and meeting the following criteria:
* Previously untreated disease
* Peripheral blood morphology, excluding other leukemia and low-grade lymphoma in leukemic phase
* Cell markers: CD5+, CD23+, SmIg (weak), CD79b-, FMC7-
* Persistent lymphocytosis (greater than 10,000/mm\^3)
* At least 40% bone marrow infiltration
* Stage 0 or I progressive disease indicated by at least one of the following:
* Persistent rise in lymphocyte count with doubling time less than 12 months
* Downward trend in hemoglobin and/or platelet count
* At least 50% increase in size of liver and/or spleen and/or lymph nodes
* Appearance of lymphadenopathy, hepatomegaly, or splenomegaly
* Constitutional symptoms caused by disease
* Pyrexia
* Night sweats
* Weight loss OR
* Stage II or III
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)\*
* SGOT/SGPT no greater than 2 times ULN\* NOTE: \* Unless due to CLL
Renal:
* Creatinine clearance at least 30 mL/min
Other:
* No other cancer or life-threatening disease
* Not pregnant
* Fertile patients must use effective contraception during and for 6 months after study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* No concurrent corticosteroids (e.g., dexamethasone) as antiemetics
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00004218
Study Brief:
Protocol Section:
NCT00004218