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

March 27, 2008
December 17, 2008
March 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00648037 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hodgkin's Disease
  • Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
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.
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.
Intervention: Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00648037
01-118
Not Provided
Trudy Small, M.D., Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Trudy Small, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP