stamcel mobilisatie bij donoren Cancer
Conditions
Interventions
Donors will receive plerixafor 320 *g/kg subcutaneously
Patients will be transplanted with the stem cells harvested with plerixafor
according to standard practice
Sponsors
HOVON
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Donors * HLA identical sibling donor * Age 18-60 years inclusive * Hematologic parameters within normal limits * Capable of undergoing leucapheresis: adequate venous access. Must be willing to undergo insertion of a central catheter should leucapheresis via peripheral vein be inadequate * Willing and able to have bone marrow aspiration if there is mobilization failure * Negative pregnancy test at study entry for women of childbearing potential * Willing and able to use adequate contraception during the mobilization period and up to 3 months after last dose of plerixafor * Written informed consent from donor ;Patients * Age 18-65 years inclusive * In general, indication for allogeneic stem cell transplant will be determined by each participating center according to local criteria. * Patients with a cytopathologically confirmed diagnosis of: - De novo Acute Myeloid Leukemia according to WHO classification in first complete remission (excluding acute promyelocytic leukemia) *- Therapy related AML/RAEB in first complete remission *- Myelodysplasia RA(RS)/RCMD with IPSS * 1.5 - Myelodysplasia refractory anemia with excess of blasts (RAEB) with IPSS * 1.5 in first complete remission * Biphenotypic leukemia in first complete remission OR - De novo B or T Lineage Acute Lymphatic Leukemia in first complete remission. * Multiple myeloma, not included in other transplant study * Hodgkin Lymphoma * Non-Hodgkin lymphoma * Chronic lymfocytic leukemia * Chronic myeloid leukemia;* WHO performance score 0,1 or 2 * Patients should have an HLA- identical sibling donor * Life expectancy >3 months * Negative pregnancy test at study entry for women of childbearing potential * Willing and able to use adequate contraception * Written informed consent from patient
Exclusion criteria
Exclusion criteria: Donors * Monozygotic twin * Unstable hypertension requiring more than 1 medication. * Positive serology for hepatitis C or HbsAg * Treatment with other investigational drugs * HIV positivity * Pregnant or breastfeeding female subject;Patients * Cardiac dysfunction * Severe pulmonary dysfunction (CTCAE grade 3-4) * Severe neurological or psychiatric disease * Significant hepatic dysfunction * Significant renal dysfunction * Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.) * Patient known to be HIV-positive * Pregnant or breast-feeding female patients. * Presence of other active non-hematological malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of donors with a successful harvest (*2.0x106 CD34+ cells /kg). | — |
Secondary
| Measure | Time frame |
|---|---|
| For donors: 1. The absolute number of CD34+ cells collected per litre processed volume. 2. The time required to collect 2.0x10^6CD34+ cells/kg, also in relation to the time of administration of plerixafor. 3. The number of CD34+ cells in the peripheral blood at regular intervals after the administration of plerixafor. 4. The number of CD34+ cells in the peripheral blood as well as in the apheresis product at regular intervals during the stem cell apheresis. 5. The phenotype of CD34+ cells and hematopoietic progenitor cells including its subpopulations, dendritic cells as well as regulatory T-cells in the graft. 6. The incidence and CTCAE grade (1-4) of adverse events. For patients: 1. incidence of engraftment at days 30, 60 and 90 after transplantation with plerixafor mobilized HPCs. 2. time to hematopoietic reconstitution. 3. hematopoietic chimerism in blood, CD3 isolated cells at days 30, 60, 90 after transplantation and in bone marrow at day 90 after transplantation. 4. incidence and grade of GVHD.. | — |
Countries
Netherlands
Outcome results
None listed