hematological malignancy leukemia
Conditions
Interventions
Patients will receive donor derived multi-antigen specific T cells 6 to 8 weeks
after the transplantation.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Before allo-SCT: - Age 18-75 years - Planned T cell depleted allo-SCT for one of these diagnoses: * Acute Lymphoblastic Leukemia in CR after prephase and first induction and consolidation therapy and WBC 20 *10E9/L, granulocytes > 0.5 *10E9/L)
Exclusion criteria
Exclusion criteria: Before allo-SCT: - Disease specific treatment foreseen in the first 6 months after SCT - Life expectation grade I for which immune suppressive treatment is given - Progressive disease for which therapy is needed - Use of > 20 mg prednisone a day - Life expectation grade I for which immune suppressive treatment is given - Progressive disease for which therapy is needed - Use of > 20 mg prednisone a day - Life expectation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cumulative incidence of acute GVHD overall grade 3 or higher needing prolonged systemic immune suppressive treatment in the three months after infusion of multi antigen-specific T cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The appearance or doubling of antigenic specific donor derived T cells in the circulation during eight weeks after the infusion of multi antigen specific T cells - Chimerism in bone marrow and peripheral lymphocytes - Loads of circulating viruses (CMV, EBV, Adenovirus) - Disease activity | — |
Countries
Netherlands
Outcome results
None listed