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:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT00003659
Eligibility Criteria:
Inclusion criteria:
* Patients must have either intermediate or high-risk chronic lymphocytic leukemia as defined by the three-stage Rai system (see section 2.2 page 2). Patients with Rai intermediate risk disease should meet the criteria for active disease as outlined by the NCI Working Group guidelines (including weight loss, fatigue, fevers, evidence of progressive marrow failure, splenomegaly, progressive lymphadenopathy, or progressive lymphocytosis with a rapid doubling time).
* Patients must be previously untreated (with cytoreductive agents) for their CLL.
* The patient must have an absolute lymphocytosis in the blood of at least 5,000 lymphocytes/μl, or bone marrow lymphocytosis greater than or equal to 30% of all nucleated cells. These lymphocytes must have an appropriate immunophenotype for CLL including expression of CD5 and CD20.
* Karnofsky performance status equal to or greater than 60% (see Appendix B).
* Eligible patients should have a reasonable life-expectancy greater than four weeks.
* Age ≥ 18 years and ≤ 75 years.
* Total bilirubin ≤ 2.0 mg per deciliter. Total creatinine ≤ 2.0 mg/ dl.
* Platelet count ≥ 50,000/ ul.
* Signed informed consent, which indicates the investigational nature of this, is required.
* No patient may be entered onto the study without consultation with the principal investigator.
EXCLUSION CRITERIA:
* Patients with Rai intermediate risk disease who meet the criteria of Montserrat "smouldering leukemia" will not be eligible for treatment on this protocol.
* Patients with significant autoimmune hemolytic anemia or autoimmune thrombocytopenia shall not be eligible for treatment on this protocol as there is some evidence that fludarabine can worsen these conditions.
* Patients with active infections requiring systemic antibiotics.
* Prior cytotoxic treatment of their CLL.
* Pregnant or lactating women. Women and men of childbearing age should use effective contraception.
* Patients with a serious cardiac condition.
* Concomitant chemotherapy or radiotherapy while on protocol.
* Concomitant prednisone therapy will not be permitted as the combination of fludarabine and prednisone is known to increase the risk of opportunistic infections. Patients may receive intravenous immunoglobulin (IVIG) and other supportive care measures as clinically appropriate while on protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00003659
Study Brief:
Protocol Section:
NCT00003659