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:
NCT00521859
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 65 years for autotransplant patients and age 18 to 60 years for allotransplant patients.
2. Patients with acute leukemia/MDS or lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or refractory relapse), or multiple myeloma (beyond first remission or unresponsive to therapy), not qualifying for treatment protocols of higher priority.
3. Adequate renal function, as defined by serum creatinine \<1.5 mg/dL.
4. Adequate hepatic function, as defined by SGPT \<3 X upper limit of normal; serum bilirubin and alkaline phosphatase \<2 X upper limit of normal, or considered not attributable to liver disease in the case of alkaline phosphatase.
5. Adequate pulmonary function with FEV1, FVC and DLCO \>50% of expected corrected for hemoglobin.
6. Adequate cardiac function with left ventricular ejection fraction \>40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
7. Zubrod performance status \<2
8. Patients receiving an allogeneic transplant must have a related or unrelated donor which meets departmental standards for donor selection.
Exclusion Criteria:
1. Uncontrolled life-threatening infections
2. HIV positive
3. A positive Beta HCG in a woman with child bearing potential as defined as not being post-menopausal for 12 or more months or no previous surgical sterilization procedures.
4. Any CNS involvement which has not been controlled for at least 4 weeks
5. Patients must be at least 21 days from prior systemic therapy for their malignancy, or have improvement of all reversible toxicities to \</= grade 2, whichever occurs first.
6. Any patient receiving Antabuse
7. Patients should be off metronidazole (Flagyl) for at least 24 hours prior to starting VNP40401M
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00521859
Study Brief:
Protocol Section:
NCT00521859