Immunotherapy for Lymphoproliferative Diseases Associated With Epstein-Barr Virus in Patients Who Have Undergone Organ Transplants
Withdrawn before enrolling · Phase 1
Conditions studied: Leukemia, Lymphoma
In brief
RATIONALE: Donor lymphocytes that have been exposed to Epstein-Barr virus may be able to help the body kill cancers associated with this virus. PURPOSE: Phase I trial to study the effectiveness of Epstein-Barr virus-specific T cells derived from matched donors in organ transplant patients with lymphoproliferative diseases associated with Epstein-Barr virus.
Key facts
- Study ID
- NCT00002956
- Run by
- University of Alabama at Birmingham
- People needed
- 0
- Starts
- 1996-11-01
- Expected to finish
- 2002-02-01
- Last updated by the study team
- 2016-03-21
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Radiographic evidence of lymphadenopathy or lymphomatous lesions combined with clinical signs of Epstein-Barr virus lymphoproliferative disease (EBV LPD), such as fevers and lymphadenopathy
- following an organ transplant Persistent, progressive, or unresponsive disease despite decreased immunosuppression, chemotherapy, or radiation therapy EBV LPD must be of host origin
- At least 4 weeks
- Patients serologically hepatitis B and C positive may receive cytotoxic
- T- lymphocytes (CTL) from donors who are serologically positive for the same virus
- Must have an HLA identical or HLA haploidentical donor
- Exclusion
- hepatic dysfunction SGOT/SGPT less than 2.5 times upper limit of normal (unless liver metastases present)
- Bilirubin less than 2.0 mg/dL
- renal dysfunction
- Creatinine clearance at greater than 50 mL/min
- cardiac dysfunction
- neurologic dysfunction
- pulmonary dysfunction
- patients developing EBV LPD who have a donor origin lymphoma
- HIV-1 positive
- Not capable of undergoing leukapheresis
Where it is running
- University of Alabama Comprehensive Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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