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

Not Applicable

Completed

• Conditions: Hodgkin's Disease; Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma
• Interventions: Drug: Rituximab

• Registration Number: NCT00648037
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2015-10-20
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-29
• Last Update Submitted: 2015-12-29
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.

Primary Outcome Measures

Name	Time	Method
Safety of Rituximab Prophylaxis	3 months post transplant	The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States