Adoptive Immunotherapy of chemotherapy refractory CMV infections using Streptamer-isolated T cells after allogeneic bone marrow or peripheral blood stem cell transplantation: a phase I/II trial - AIT-CMV-Stage-01

Conditions: -chronic persistent CMV infection after allogeneic bone marrow or peripheral blood stem cell transplantation, refractory to antiviral chemotherapy

Registration Number: EUCTR2006-006146-34-DE

Lead Sponsor: Stage Pharmaceuticals GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

- patient planned for or after allogeneic bone marrow or peripheral blood stem cell transplantation with a chronic persistent CMV infection refractory to antiviral chemotherapy

- healthy CMV-seropositive donor who had donated the stem cells in the first place and who will also be considered to donate the CMV-specific lymphocytes

- matched unrelated donor (third party donor) if donor who had donated stem cells is CMV seronegative

- Streptamer reagents for HLA-typ of patient available

- donor and patient agreed to participate in the trial
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- immunosuppressive treatment with > 1mg/kg prednisolon

- acute graft versus host disease grade III or IV at time point of transfer

- missing written consent of donor and/or patient

- diseases affecting the haelth of donor or patient

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Toxicity<br><br>Safety and toxicity of a adoptive immunetherapy with Streptamer isolated T lymphocytes of the bone marrow or peripheral stem cell donor;Secondary Objective: Effectivity<br><br>Redution in viral load, viral elimination<br><br>Induction of CMV-specific T-cell response in the recipient;Primary end point(s): Drop in CMV viral load in the circulation estimated by PCR

Secondary Outcome Measures