stem cell mobilization MedDRA version: 12.1 Level: LLT Classification code 10053948 Term: Hematopoietic stem cell mobilization MedDRA version: 12.1 Level: LLT Classification code 10024329 Term: Leukemia MedDRA version: 12.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: MOZOBIL
Product Name: plerixafor
Pharmaceutical Form: Solution for injection
Product Name: hematopoietic stem cells
Product Code: HPCs
Pharmaceutical Form: Intravenous infusion
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
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 and collection period • Written informed consent from donor Patients • Age 18-65 years inclusive • Patients with a cytopathologically confirmed diagnosis of: - De novo Acute Myeloid Leukemia according to WHO classification in first complete remission (excluding acute promyelocytic leukemia) OR - Myelodysplasia refractory anemia with excess of blasts (RAEB) with IPSS = 1.5 in first complete remission OR - Therapy related AML/RAEB in first complete remission OR - Biphenotypic leukemia in first complete remission OR - De novo B or T Lineage Acute Lymphatic Leukemia in first complete remission. • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 • Patients who are treated with a kinase-inhibitor • 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 malignancy or a history of active malignancy during the past 5 years, other than non melanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility of plerixafor 320 µg/kg subcutaneously and of plerixafor 320 µg/kg intravenously to harvest a sufficient number of CD34+ peripheral blood stem cells/kg recipient body weight. Feasibilty is defined as a minimum of 2.0x106/kg CD34+ cells in one or two phereses in at least 90% of the donors ;Secondary Objective: Donors: 1. To determine the efficacy (nr of CD34+ cells / liter processed blood volume)of plerixafor in both arms. 2. To determine the time interval that is required to obtain 2.0 x 106 CD34+ cells/kg . 3. To determine the number of CD34+ cells in the peripheral blood at regular intervals after the administration of plerixafor. 4. To determine the number of CD34+ cells in the peripheral blood and the apheresis product at regular intervals during the stem cell apheresis. 5. To determine the phenotype of plerixafor mobilized CD34+ cells both in peripheral blood and collected stem cells. Patients: 1. To document engraftment 30, 60 and 90 days after transplantation with an allograft harvested after mobilization with plerixafor 320 µg/kg subcutaneously or intravenously. 2. To document hematopietic reconstitution. 3. To study chimerism in peripheral blood and T-cells 30, 60 and 90 days, and chimerism in bone marrow 90 days . ;Primary end point(s): Percentage of donors in each arm with a successful harvest (=2.0x106 CD34+ cells /kg). | — |
Countries
Netherlands
Outcome results
None listed