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:
Memorial Sloan-Kettering Cancer Center
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
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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
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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013