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

December 29, 2015 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rituximab
Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
Drug: Rituximab
Rituximab 375 mg/m^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is > 200 cells/ul or a maximum of 6 doses have been given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Rituximab Prophylaxis
Time Frame: 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.
3 months post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (ESTIMATE)

April 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2016

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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