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
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2008 |
| End Date: | December 2008 |
Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT
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 medicine has been approved by the Food and Drug Administration to treat
patients with other types of lymphomas, and has been used to treat a small number of
patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to
try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore
experimental.
the monthly administration of an (antibody) protein against B lymphocytes called Rituximab.
Although this medicine has been approved by the Food and Drug Administration to treat
patients with other types of lymphomas, and has been used to treat a small number of
patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to
try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore
experimental.
Inclusion Criteria:
- 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 Criteria:
- 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.
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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