Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV

Inclusion Criteria

• •Patient age \< 22 years.
• •Both genders and all races are eligible.
• •The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
• •Must be willing to sign a written informed consent.
• •Patient Organ Status at the time of enrollment (pre-transplant)
• •* Lansky or Karnofsky score \> 50
• •* Echocardiogram shortening fraction \> 27%
• •* Renal function: serum creatinine \< 2 x normal for age
• •* DLCO \> 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients.
• •* Hepatic: AST, ALT \< 5x upper limit of normal; bilirubin \< 2.0 mg/dl
• •Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom.
• •Patients must be between 28 and 100 days post T-cell depleted allogeneic HPCT
• •Patients must meet the following criteria (within 72 hours of CTL infusion):
• •* Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days.
• •* No oxygen requirement with oxygen saturations \> 90%.
• •* AST, ALT \< 5x upper limit of normal for age; bilirubin \< 2 mg/dl.
• •* Hemoglobin \> 8 gm/dl prior to infusion. (May be transfusion dependent).
• •* Renal function: serum creatinine \< 2 x normal for age.
• •The Patient must not have the following conditions on the day of CTL infusion:
• •* Exhibit overt hematologic manifestations of relapse or persistent disease.
• •* Evidence of recurrent/persistent disease based primarily on flow cytometry, cytogenetics, chimerism analysis, or other molecular studies does not by itself represent grounds for exclusion.