Prospective clinical trial for the evaluation of safety and efficacy of virus-specific T-cells for the prevention or treatment of cytomegaly or Epstein-Barr virus infection in patients after allogeneic stem cell transplantation. The treatment will be compared to standard treatment. The allocation to treatment arms is done randomly. The trial will be conducted at several study sites.

Phase 1

• Conditions: Immune deficiency after allogeneic stem cell transplantation; MedDRA version: 19.0Level: PTClassification code 10007877Term: Cell-mediated immune deficiencySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-004240-30-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Male or female person of 18 to 75 years of age
•Unlimited ability to provide informed consent
•Written informed consent
•Indication for allogeneic stem cell transplantation
•HLA-identical donor, related or unrelated, HLA match: 10/10
•Stem cell source: G-CSF mobilised peripheral blood stem cells
•Positive EBV serology of the donor
•Positive CMV serology of the donor
•Effective contraception for females of child-bearing potential

Are the trial subjects under 18? no
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Donor seronegative for EBV
•Donor seronegative for CMV
•Bone marrow or umbilical blood as stem cell source
•Alemtuzumab (Campath®) for conditioning
•Sorror score >3
•Known hypersensitivity to one of the ingredients of the IMP
•Pregnant or breast-feeding female

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified