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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38068

Enrollment

Registered

2012-04-01

Start date

2013-09-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematological malignancy leukemia

Interventions

Administration of HA-1 TCR transduced virus-specific donor T-cells 8 weeks after allo-SCT. This administration may be repeated 6 weeks later.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • Life expectation

Design outcomes

Primary

Measure	Time frame
• The number of events of acute GvHD, all other adverse events and death. • The feasibility of generation of HA-1 TCR transduced virus-specific donor T-cells.	—

Secondary

Measure	Time frame
• The number of HA-1 TCR transduced virus-specific donor T-cells in blood or bone marrow at different time points. • The number of patients eligible for standard DLI at 6 months.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)