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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00374933
Eligibility Criteria:
Patient-related Parameters:
* Patients must have a healthy histocompatible donor (A, B and DR match); either sibling or unrelated volunteer identified through the NMDP
* Age between 18 and 70 years old
* Life expectancy greater than 3 months.
* ECOG performance status 0-1.
* Patients must have acceptable organ function:
* total bilirubin \<2.0
* AST and ALT \< 3 x normal, unless increases are thought to be either from non-hepatic causes (i.e hemolysis) or related to underlying disease (such as liver involvement with leukemia);
* creatinine \<2.0 or creatinine clearance \>40 ml/min (calculated or collected);
* Cardiac: An ejection fraction \>40% on MUGA or echocardiogram;
* Pulmonary: corrected DLCO \>50%
Exclusion Criteria:
Subjects:
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study. Patients must have recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patients with uncontrolled or untreated central nervous system involvement
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* HIV positive patients are excluded
* Pregnant women
* Patients who are breastfeeding
Donors:
* Sibling donors will be evaluated according to the standard practice of the University of Pennsylvania Bone Marrow and Stem Cell Transplant Program
* Unrelated donor evaluations and consent will be performed by an NMDP donor center according to standard guidelines and procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00374933
Study Brief:
Protocol Section:
NCT00374933