Enhancing Graft vs Leukemia Via Delayed Ex-Vivo Co-Stimulated DLI After Non-Myeloablative Stem Cell Transplantation

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.