relapsed mature B cell neoplasm
Conditions
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 str
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Life expectation 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactJ.H.F. Falkenburg
P.O. Box 9600
Outcome results
None listed