Skip to content

Use of Virus-Specific Lymphocytes for Treatment of Patients with Low Immunity After Bone Marrow Transplantation

Expansion of virus specific lymphocytes for cell therapy in immunosuppressed patients submitted to bone marrow transplant - : Cell therapy for CMV infection in transplanted patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-8zzwfn
Enrollment
Unknown
Registered
2019-03-20
Start date
2020-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infection

Interventions

First, anti-allergic medication such as diphenhydramine at a dose of 1mg/kg and antipiretic such as dipyrone or paracetamol will be administered. After administration of anti-allergy and antipiretic
Biological/vaccine
A11.118.637.555.567.569

Sponsors

Sociedade Beneficente Israelita Brasileira - Hospital Israelita Albert Einstein
Lead Sponsor
Sociedade Beneficente Israelita Brasileira - Hospital Israelita Albert Einstein
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Reduction in cytomegalovirus viral load as measured by laboratory tests.

Secondary

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactNelson Hamerschlak

Sociedade Beneficente Israelita Brasileira - Hospital Israelita Albert Einstein

hamer@einstein.br+55-11-21511353

Outcome results

None listed

Source: REBEC (via WHO ICTRP)