Donor Lymphocyte Infusion after Stem Cell Transplant for the Treatment of Blood Cancer

Inclusion Criteria

• Age 18 years or older
• Subjects must have histologic or cytologic confirmation of ANY hematologic malignancy
• Allogeneic stem cell transplant is indicated as management of underlying hematologic malignancy
• Patient has organ function (cardiac, lung and liver) considered adequate to undergo conditioning chemotherapy and allogeneic stem cell transplant in the assessment of the clinical program
• Patient has a 10/10 HLA-matched sibling donor OR has a HLA-haploidentical donor available (in the absence of a 10/10 HLA matched unrelated donor)
• The related transplant donor is willing, available and consents to undergo a second, non-mobilized leukapheresis for the procurement of donor lymphocytes
• The related transplant donor is 18 years of age or older
• Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Subject is unwilling to receive a prophylactic donor lymphocyte infusion per study protocol
• The related donor is unwilling or unavailable to undergo a second, non-mobilized leukapheresis for the procurement of donor lymphocytes
• Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry and for the duration of study participation. Women of child bearing age must have documented negative pregnancy test prior to start of conditioning regimen for stem cell transplantation and a repeat negative pregnancy test prior to infusion of the lymphocyte product
• Left ventricular ejection fraction (LVEF) < 45%
• Carbon monoxide diffusing capability test (DLCO) < 45% of expected value corrected for alveolar volume and hemoglobin
• Serum creatinine > 2 times the upper limit of normal