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

Leukemia Clinical Trial

Official title:

Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648037
• Other study ID #: 01-118
• Status: Completed
• Phase: N/A
• First received: March 27, 2008
• Last updated: December 29, 2015
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Leukemia
• Lymphoma, Non-Hodgkin
• Lymphoproliferative Disorders
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Non-Hodgkin's Lymphoma
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Rituximab Prophylaxis	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	Yes

External Links

•   Memorial Sloan-Kettering Cancer Center