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

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00648037
First received: March 27, 2008
Last updated: December 17, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Hodgkin's Disease
Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Drug: Rituximab

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLAmismatched related HSCT. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To examine B cell reconstitution in patients receiving Rituximab prophylaxis following TCD unrelated and TCD HLA-mismatched related HCT. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the incidence of acute and chronic graft versus host disease in recipients of a TCD unrelated or HLA-mis-matched HCT who receive Rituximab. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients (n=25) following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
Drug: Rituximab
Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab 375 mg/m2 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648037

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Trudy Small, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Trudy Small, M.D., Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00648037     History of Changes
Other Study ID Numbers: 01-118
Study First Received: March 27, 2008
Last Updated: December 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
RITUXIMAB
Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014