search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number12412
- NTR NumberNTR3454
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mei-2012
- Secondary IDs2010-03 METC LUMC
- Public TitleADMINISTRATION OF HA-1 TCR TRANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA.
- Scientific TitleADMINISTRATION OF HA-1 TCR RANSDUCED VIRUS-SPECIFIC T-CELLS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN PATIENTS WITH HIGH-RISK LEUKEMIA.
- ACRONYMHA-1 TCR transduced virus-specific T-cells
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedHigh risk leukemia
- Inclusion criteria1. 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 criteria1. Life expectation < 3 months;
2. End stage irreversible multi-system organ failure;
3. Pregnant or lactating women;
4. Severe psychological disturbances;
5. HIV-positivity.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2012
- planned closingdate1-jun-2015
- Target number of participants20
- InterventionsInfusion 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 be repeated 6 weeks later.
- Primary outcome1. 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 outcome1. 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.
- Timepoints1. Weekly, first 8 weeks after infusion(s);
2. Three weekly, next 2-3 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. S. Kersting
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.H.F. Falkenburg
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryThis is an open-label non-randomized phase I/II feasibility study to treat patients with high-risk leukemia with HA-1 TCR transduced virus-specific donor-derived T-cells 8 and 14 weeks after allo-SCT. The HA-1 TCR transduced virus-specific T-cells will be generated from donor leukocytes obtained from a leukapheresis product of the stem cell donor. Minimally one and maximally two CMV- and/or EBV-specific T cell populations will be isolated from PBMC using Streptamers. After 2-3 days of culture, virus-specific T-cells are transduced with a retroviral vector encoding the HA-1-TCR. After 8-12 days of additional culturing, the transduced virus-specific T-cells will be analyzed for virus-specific T-cell purity and HA-1-TCR cell surface expression using virus- and HA-1-specific tetramers. For release of the HA-1-TCR transduced virus-specific T-cells, 95% of the cell product must be T-cells, 60% of T-cells must be antigen-specific as measured with tetramers specific for the endogenous virus-TCR and introduced HA-1-TCR, and 5% of lymphocytes must be HA-1-tetramer positive. The maximal amount of virus- or HA-1-tetramer negative T-cells with unknown specificity administered in the T-cell product is <0.3 x 106 cells/kg body weight in patients transplanted with HLA-matched related donors and <0.15 x 106 cells/kg body weight in patients transplanted with unrelated donors or HLA-A2 mismatched donors.
- Main changes (audit trail)
- RECORD24-mei-2012 - 11-jun-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl