Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT
- Patient must be a recipient of aT cell depleted unrelated or HLA mis-matched related
HSCT for the treatment of a malignancy or immunodeficiency disease.
- Patients must have an ANC > or = to 1500 cells/ul on the day of first treatment.
- Patients with acute or chronic leukemia, or MDS prior to transplant must be in
remission defined as <5% blasts in the bone marrow.
- Patient with must be in remission.
- Patient must be Hepatitis B surface antigen negative pre transplant.
- Patients must have adequate cardiac function defined as a left ventricular ejection
fraction at rest of >50% documented pre-transplant.
- Patient may be of either gender and of any ethnic background.
- Patient may be of any age. There is no upper age restriction.
- Patients or their guardians must be able to understand the nature and risk of the
proposed study and be able to sign consent.
- Karnofsky score <70%
- Female patients who are pregnant or lactating.
- Evidence of EBV-LPD or circulating EBV copy number >1000.
- Active uncontrolled bacterial or fungal infection.
- Prior history of Hepatitis B infection or Hepatitis B surface antigen positivity pre
- HIV-1,2 sero-positive patients.
- Patients or guardians not signing informed consent.
- Patients with prior allergic reaction to Rituximab or other murine monoclonal
- Patients taking other investigational agents under another protocol unless discussed
and approved in advance by Genentech and the IDEC Therapeutic Director.