ADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA (LUMC 2010-02)

Phase 2

Completed

• Conditions: leukemia; hematological malignancy; 10024324

• Registration Number: NL-OMON38068
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-08-29
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• The number of events of acute GvHD, all other adverse events and death.<br /><br>• The feasibility of generation of HA-1 TCR transduced virus-specific donor<br /><br>T-cells.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The number of HA-1 TCR transduced virus-specific donor T-cells in blood or<br /><br>bone marrow at different time points.<br /><br>• The number of patients eligible for standard DLI at 6 months.</p><br>