hematologische maligniteiten - hematological malignancies allogene stamceltranplantatie - allogeneic stem cell transplantation
Conditions
Interventions
Infusion of CD4+ donor lymphocytes 3 months after transplantation.
Sponsors
Leiden University Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years; 2. Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who underwent an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ; 3. Life expectation of > 3 months; 4. WHO performance status of 0, 1 or 2; 5. Written informed consent according to the rules and regulations of the Leiden University Medical Center.
Exclusion criteria
Exclusion criteria: 1. Use of systemic immunosuppressive treatment (due to GVHD); 2. Acute GVHD of the skin > grade 2 or progressive acute GVHD; 3. Progressive disease needing cytoreductive treatment; 4. Any concomitant disease preventing the safe administration of donor lymphocytes; 5. Severe psychological disturbances; 6. Severely limited life expectation due to diseases other than the malignancy; 7. Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lymphocyte chimerism status; 2. Transplantation related complications between 3 and 12 months after the transplantation (CMV disease or CMV reactivation needing systemic treatment, EBV reactivation needing systemic treatment, VZV infection, other infections for which hospitalization, GVHD needing systemic treatment, auto-immune disorders needing systemic treatment). | — |
Contacts
Public ContactC.J.M. Halkes
LUMC - C2-R140 Postbus 9600
Outcome results
None listed