Status:
COMPLETED
Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Hodgkin's Disease
Leukemia
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this me...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 transplant.
- HIV-1,2 sero-positive patients.
- Patients or guardians not signing informed consent.
- Patients with prior allergic reaction to Rituximab or other murine monoclonal antibody.
- Patients taking other investigational agents under another protocol unless discussed and approved in advance by Genentech and the IDEC Therapeutic Director.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00648037
Start Date
March 1 2008
End Date
December 1 2008
Last Update
February 1 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065