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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26148

Enrollment

Registered

2012-05-24

Start date

2012-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

high risk leukemia

Interventions

Infusion of manipulated donor lymphocytes consisting HA-1 T-cell receptor (TCR) transduced virus-specific donor T-cells 8 weeks after allogeneic stem cell transplantation (allo-SCT). This infusion may

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years; 2. WHO performance score 0-2; 3. High-risk leukemia; 4. Complete remission (CR) or stable partial remission (PR); 5. HLA-A*0201 positive; 6. HA-1h positive; 7. Availability of a suitable donor; 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Life expectation < 3 months; 2. End stage irreversible multi-system organ failure; 3. Pregnant or lactating women; 4. Severe psychological disturbances; 5. HIV-positivity.

Design outcomes

Primary

Measure	Time frame
1. The number of events of acute GvHD, all other adverse events and death; 2. The feasibility of generation of HA-1 TCR transduced virus-specific donor T-cells.	—

Secondary

Measure	Time frame
1. The number of HA-1 TCR transduced virus-specific donor T-cells in blood or bone marrow at different time points; 2. The number of patients eligible for standard DLI at 6 months.	—

Contacts

Public ContactP. Balen, van

P.O. Box 9600

stafsecretariaathematologie@lumc.nl+31 (0)71 5262267

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)