N/A
N=26
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
Hodgkin's Disease · Leukemia · Myelodysplastic Syndrome · Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00648037 ↗Enrolled (actual)
26
Serious AEs
23.1%
Results posted
Feb 2016
Primary outcome: Primary: Safety of Rituximab Prophylaxis — 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rituximab (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Rituximab Prophylaxis |
23 | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT00648037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.