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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00003658
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Intermediate- or high-risk chronic lymphocytic leukemia (CLL) as defined by the three-stage Rai system
* Rai intermediate disease must be active disease (including weight loss, fatigue, fevers, evidence of progressive marrow failure, splenomegaly, progressive lymphadenopathy, and progressive lymphocytosis with a rapid doubling time)
* Other low-grade B-cell neoplasms, including small lymphocytic lymphoma (and its variants), Waldenstrom's macroglobulinemia, and follicular lymphoma allowed
* Autoimmune hemolytic anemia or autoimmune thrombocytopenia allowed regardless of disease stage
* B-cells demonstrated by immunophenotypic (or immunohistochemical) analysis of the malignant lymphocytes
* Must be previously treated
* For CLL, absolute lymphocytosis in the blood at least 5,000 lymphocytes/mm\^3 OR
* Bone marrow lymphocytosis at least 30% of all nucleated cells
* No Rai intermediate-risk disease that meets the criteria of Montserrat "smoldering leukemia" NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* More than 4 weeks
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* No active infections requiring systemic antibiotics
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior biologic therapy
* Concurrent intravenous immunoglobulin allowed
* Concurrent epoetin alfa allowed
Chemotherapy:
* At least 4 weeks since prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Concurrent prednisone therapy allowed as long as dose is stable or decreasing over the past 4 weeks
* No increase in prednisone therapy while on study
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003658
Study Brief:
Protocol Section:
NCT00003658