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 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT00968461
Eligibility Criteria:
Inclusion Criteria:
1. All patients with a histologically or cytologically confirmed lymphoproliferative disorder previously treated with fludarabine are eligible for this protocol.
2. Patients must be 18 years of age or older.
3. Patients must have a performance status of 0-2 (Zubrod scale).
4. Patients must have adequate renal function (serum creatinine \</= 2 mg/dL or creatinine clearance \> 50 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
5. Patients must have adequate function (bilirubin \</= 2.0 mg/dl; SGOT or SGPT \</= 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder \[for bilirubin\]). Patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
6. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Exclusion Criteria:
1. Untreated or uncontrolled life-threatening infection (Grade 4 infection, i.e. septic shock, hypotension, acidosis, necrosis).
2. Pregnancy or breastfeeding. Female patients of childbearing potential (including those \<1 year postmenopausal) and male patients must agree to use contraception. A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
3. Chemotherapy and/or radiation therapy within 4 weeks of study enrollment.
4. Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00968461
Study Brief:
Protocol Section:
NCT00968461