Clinical trial NCT00648037: 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
Official title: Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin's Disease
Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Keywords: RITUXIMAB
Lymphoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-04-01
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety of Rituximab Prophylaxis
timeFrame: 3 months post transplant
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Trudy Small, MD
role: PRINCIPAL_INVESTIGATOR
References: