ADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA

Phase 1

Conditions: high risk leukemia
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2010-024625-20-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

• Age 18-75 years
• WHO performance score 0-2
• High-risk leukemia (see appendix D)
• Complete remission (CR) or stable partial remission (PR) (see appendix D)
• HLA-A*0201 positive
• HA-1h positive
• Availability of a suitable donor (see donor criteria)
• Written informed consent
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

• Life expectation < 3 months.
• End stage irreversible multi-system organ failure.
• Pregnant or lactating women.
• Severe psychological disturbances.
• HIV-positivity

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To investigate the feasibility and safety of administration of donor HA-1 TCR transduced virus-specific T cells after allo-SCT.;Secondary Objective: • To evaluate the persistence of donor HA-1 TCR transduced virus-specific T cells after administration.<br>• To evaluate whether administration of HA-1 TCR transduced virus-specific T cells after allo-SCT makes patients eligible for standard DLI at 6 months after allo-SCT.<br>;Primary end point(s): • The number of events of acute GvHD, all other adverse events and death.<br>• The feasibility of generation of HA-1 TCR transduced virus-specific T cells.;Timepoint(s) of evaluation of this end point: - interim analysis will be performed by the principal investigator after treatment of the first 3, 6 and10 patients <br>- End of the study is defined as 18 weeks after the first infusion of HA-1 TCR transduced virus-specific T-cells of patient number 20. Subsequently the patients will be followed until death or last follow-up.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • The number of HA-1 TCR transduced virus-specific T cells in blood or bone marrow at different time points.<br>• The number of patients eligible for standard DLI at 6 months.;Timepoint(s) of evaluation of this end point: - interim analysis will be performed by the principal investigator after treatment of the first 3, 6 and10 patients <br>- End of the study is defined as 18 weeks after the first infusion of HA-1 TCR transduced virus-specific T-cells of patient number 20. Subsequently the patients will be followed until death or last follow-up.