se of Virus-Specific Lymphocytes for Treatment of Patients with Low Immunity After Bone Marrow Transplantatio
Phase 1
Not yet recruiting
- Conditions
- Cytomegalovirus Infection
- Registration Number
- RBR-8zzwfn
- Lead Sponsor
- Sociedade Beneficente Israelita Brasileira - Hospital Israelita Albert Einstein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Patients of both sexes. Patients who have undergone allogeneic bone marrow transplantation. Patients who have cytomegalovirus infection or reactivation without clinical improvement or CMV copy decline after at least 2 weeks of treatment with standard anti-viral therapy.
Exclusion Criteria
Patients who have received ATG, Campath or other immunosuppressive monoclonal antibody in less than 28 days. Patients who have received infusion of donor lymphocytes in less than 28 days. Patients with other uncontrolled infections than cytomegalovirus. Patients with Grade II to IV active graft versus host disease (GVHD). Patients receiving corticosteroid therapy with equivalent or higher doses of prednisone 0.5mg/kg.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in cytomegalovirus viral load as measured by laboratory tests.
- Secondary Outcome Measures
Name Time Method Grading of adverse reactions, such as graft versus host disease with annotations in relation to cutaneous rash, diarrhea and liver function. Adverse reactions should also be measured by laboratory tests such as bilirubin, alkaline phosphatase, gamma-GT, TGO and TGP, blood counts with platelet counts, renal function with creatinine, and urea.