|- candidate number||14034|
|- NTR Number||NTR3722|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-nov-2012|
|- Secondary IDs||2010-01 METC LUMC|
|- Public Title||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.|
|- Scientific Title||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.|
|- ACRONYM||Leukemia reactive T cells|
|- Healt Condition(s) or Problem(s) studied||Relapsed mature B cell neoplasm|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2013|
|- planned closingdate||1-jan-2016|
|- Target number of participants||20|
|- Interventions||Infusion 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 outcome||1. 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 outcome||1. 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.
|- Timepoints||Weekly, first 12 weeks after infusion.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.H.F. Falkenburg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I. Jedema|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|KWF Kankerbestrijding, ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||This 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)|
|- RECORD||27-nov-2012 - 28-dec-2012|