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Administration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement.


- candidate number14034
- NTR NumberNTR3722
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-nov-2012
- Secondary IDs2010-01 METC LUMC
- Public TitleAdministration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement.
- Scientific TitleAdministration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement.
- ACRONYMLeukemia reactive T cells
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedRelapsed mature B cell neoplasm
- Inclusion criteria1. Allo-SCT patient with a sibling or unrelated stem cell donor matched for at least HLA-A, -B, -C, and –DR alleles (8/8);
2. Age 18-75 years;
3. WHO performance score 0-2;
4. Persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement at least 3 months after last donor immune cell infusion (allo-SCT or DLI);
5. Possibility to collect > 5 x 10^7 mononuclear cells containing > 40% malignant B cells from blood or bone marrow of patient, or availability of patient malignant B cells cryopreserved at a GMP-facility;
6. Donor willing to donate PBMC, or cryopreserved donor PBMC available in an amount of ≥1 x 10^9 MNC/ total;
7. Written informed consent.
- Exclusion criteria1. Life expectation < 3 months;
2. End stage irreversible multi-system organ failure;
3. Acute GvHD overall grade ≥ II;
4. Treatment with corticosteroids in an equivalent dose of >0.5 mg/kg prednisone;
5. Expectation of necessity to administer chemotherapy within 3 months after administration of leukemia-reactive T cells;
6. Pregnant or lactating women;
7. Severe psychological disturbances.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-jan-2016
- Target number of participants20
- InterventionsInfusion of leukemia-reactive T cells. Infusion will take place at daycare. A second infusion will be given after six weeks when the first infusion is well tolerated. The product is prepared under strict circumstances.
There will be no control group.
- Primary outcome1. The number of acute GvHD, other serious adverse events and deaths within 12 weeks after last infusion of leukemia-reactive T cells;
2. The feasibility of generation of leukemia-reactive T cells for administration.
- Secondary outcome1. Increase in number of leukemia-reactive T cells in blood and/or bone marrow at different time points after infusion of leukemia-reactive T cells;
2. CR, PR and MR rate 12 weeks after last infusion of leukemia-reactive T cells;
3. Time to next leukemia/lymphoma treatment.
- TimepointsWeekly, first 12 weeks after infusion.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.H.F. Falkenburg
- CONTACT for SCIENTIFIC QUERIESDr. I. Jedema
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThis is an open-label non-randomized phase I/II feasibility study to administer leukemia-reactive T cells to 20 patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement at least 3 months after allo- SCT or DLI, in a maximal dose of 1x10^6 adoptively transferred cells per kg bodyweight of the patient.
First, malignant cells will be collected from the patient and cryopreserved under GMP conditions (if no cryopreserved malignant cells are available). Secondly, a leukapheresis product will be obtained from the donor.
The leukemia-reactive T cells will be generated from the PBMC from the leukapheresis product as summarized in the investigational medicinal product chapter of the protocol.
The leukemia-reactive T cells will be administered to the patient when the product meets the release criteria and the patient has no contraindications for administration of the cells. When the infusion of the leukemia-reactive T cell product is well tolerated by the patient, a second product will be generated and infused 6 weeks later.
Follow-up will be performed until 12 weeks after administration of the last T cell product or until subsequent DLI, whichever comes first. From then, routine follow up will be performed.
- Main changes (audit trail)
- RECORD27-nov-2012 - 28-dec-2012


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