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

NCT00648037 | Completed Results

• 1 other identifier: 01-118
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hodgkin's Disease; Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma

Keywords

RITUXIMAB; Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Rituximab

EXPERIMENTAL

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

Interventions

Rituximab DRUG

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.

Rituximab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Hodgkin Disease; Leukemia; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Papadopoulos, Esperanza, MD (Attending)
• Organization: Memorial Sloan Kettering Cancer Center

papadope@mskcc.org

+1212-639-8276

Study Officials

• Trudy Small, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 1, 2016
• Results First Posted: February 1, 2016

Record last verified: 2015-12

Locations

US (1)