T-cell Therapy for CMV (Cytomegalovirus) Disease

Phase 1

Completed

• Conditions: CMV disease; Infection - Other infectious diseases

• Registration Number: ACTRN12609000531213
• Lead Sponsor: Queensland Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) HSCT/SOT recipients who were transplanted by, and/or are currently under the care of, a haematologist or physician at the appropriate clinical facility.
2). CMV infection that falls into one of the following categories:
(a) Recurrent CMV reactivation (as defined by PCR) or disease (as defined by histology) following successful initial therapy, or
(b) Persistent CMV disease (no response to 2 weeks of salvage foscarnet or other second line antiviral agent), or
(c) Persistent CMV replication (more than 6 weeks by PCR) despite appropriate antiviral therapy, or
(d) Any CMV reactivation or disease where anti-viral therapy is contraindicated on the basis of intolerance or end organ limitation (e.g. renal impairment, marrow dysfunction).
3) Absence of uncontrolled intercurrent infection
4) Patient able to provide informed consent
5) Age 18 to 75

Exclusion Criteria

1 Uncontrolled intercurrent infection
2 Eastern Cooperative Oncology Group (ECOG)status > 3 (Karnofsky performance score < 30: disabled, no self-care. Totally bedridden, or confined to chair)
3 Markers of active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) infection (presence of Hepatitis B surface Antigen (HBsAg), Hepatitis C (HepC) antibody, or HIV antibodies)
4 Uncontrolled Graft versus Host disease (GVHD)
5 Steroid doses > 1mg/kg of prednisone, or equivalent

Study & Design

• Study Type: Interventional
• Study Design: Not specified