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The feasibility and efficacy of subcutaneous and intravenous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: A randomized phase II study.


- candidate number9699
- NTR NumberNTR2929
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2011
- Secondary IDsHO107 HOVON
- Public TitleThe feasibility and efficacy of subcutaneous and intravenous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: A randomized phase II study.
- Scientific TitleThe feasibility and efficacy of subcutaneous and intravenous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: A randomized phase II study.
- ACRONYMHOVON 107 MOBILIZATION
- hypothesisThe hypothesis to be tested is the feasibility of arm A and arm B.
- Healt Condition(s) or Problem(s) studiedStem cell transplantation , Leukemia, Myelodysplasia, Plerixafor
- Inclusion criteriaDonors:
1. HLA identical sibling donor;
2. Age 18-60 years inclusive;
3. Hematologic parameters within normal limits;
4. Capable of undergoing leucapheresis: Adequate venous access. Must be willing to undergo insertion of a central catheter should leucapheresis via peripheral vein be inadequate;
5. Willing and able to have bone marrow aspiration if there is mobilization failure;
6. Negative pregnancy test at study entry for women of childbearing potential;
7. Willing and able to use adequate contraception during the mobilization and collection period;
8. Written informed consent from donor.

Patients:
1. Age 18-65 years inclusive;
2. Patients with a cytopathologically confirmed diagnosis of:
A. De novo Acute Myeloid Leukemia according to WHO classification in first complete remission (excluding acute promyelocytic leukemia) OR;
B. Myelodysplasia refractory anemia with excess of blasts (RAEB) with IPSS ≥ 1.5 in first complete remission OR;
C. Therapy related AML/RAEB in first complete remission OR;
D. Biphenotypic leukemia in first complete remission OR;
E. De novo B or T Lineage Acute Lymphatic Leukemia in first complete remission.
3. WHO performance score 0,1 or 2;
4. Patients should have an HLA-identical sibling donor;
5. Life expectancy >3 months;
6. Negative pregnancy test at study entry for women of childbearing potential;
7. Willing and able to use adequate contraception;
8. Written informed consent from patient.
- Exclusion criteriaDonors:
1. Monozygotic twin;
2. Unstable hypertension requiring more than 1 medication;
3. Positive serology for hepatitis C or HbsAg;
4. Treatment with other investigational drugs;
5. HIV positivity;
6. Pregnant or breastfeeding female subject.

Patients:
1. Patients who are treated with a kinase-inhibitor;
2. Cardiac dysfunction;
3. Severe pulmonary dysfunction (CTCAE grade 3-4);
4. Severe neurological or psychiatric disease;
5. Significant hepatic dysfunction;
6. Significant renal dysfunction;
7. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
8. Patient known to be HIV-positive;
9. Pregnant or breast-feeding female patients;
10. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jul-2011
- planned closingdate15-jul-2013
- Target number of participants60
- InterventionsArm A: Donors will receive plerixafor 320 μg/kg subcutaneously;
Arm B: Donors will receive plerixafor 320 μg/kg intravenously.
- Primary outcomeTo 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 outcomeDonors:
1. To determine the efficacy of plerixafor in both arms Efficacy will be determined as follows: the absolute number of CD34+ cells collected per liter processed blood volume;
2. To determine the time interval that is required to obtain 2.0 x 106 CD34+ cells/kg from start of mobilization procedure;
3. Pharmacokinetics: 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 as well as in the apheresis product at regular intervals during the stem cell apheresis;
5. To determine the phenotype of plerixafor mobilized CD34+ cells including progenitor cells, dendritic cells and regulatory T-cells both in peripheral blood and collected stem cells;
6. To document adverse events grade 2-4 following mobilization by plerixafor.

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 i.e neutrophils and patelets;
3. To study chimerism in peripheral blood and T-cells 30, 60 and 90 days, and chimerism in bone marrow 90 days after transplantation with an allograft harvested after mobilization with plerixafor 320 μg/kg subcutaneously or intravenously;
4. To evaluate the incidence and grade of graft versus host disease (GVHD).
- TimepointsDonor:
At entry, just before and after plerixafor administration and stem cell apharesis, 6 weeks, 6 months, 1 year and 2 years after stem cell apheresis.

Patient:
At entry, after the allogeneic transplant patients will be seen regularly according to the institutional guidelines. In general they will be seen 1-2 times weekly for the first month, 1 time every 2 weeks in the second and third month. After 3 months patients will be seen regularly in a frequency also determined by the clinical situation. Clinical and bone marrow evaluations will be done at least after 3, 6, 12, 18, 24 months. After 2 years of follow up patients will be seen on a 1-2 yearly basis for the rest of their lifes, according to local protocol.
- Trial web sitewww.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. G.E. Greef, de
- CONTACT for SCIENTIFIC QUERIESDr. G.E. Greef, de
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Genzyme Corporation, Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsN/A
- Brief summaryStudy phase:
Phase II.

Study objective:
To determine the feasibility of plerixafor 320 μg/kg subcutaneously and intravenously to harvest a sufficient number of peripheral blood stem cells in healthy HLA-matched sibling donors.

Donor/Patient population:
Healthy HLA- matched adult sibling donors for hematopoietic stem cells. Patients eligible for allogeneic stem cell transplantation according to standard criteria.

Study design:
The study will be performed as a prospective randomized phase II study.

Duration of treatment:
For arm A the stem cell collection will take place the following day starting 9 hours after the subcutaneous administration of plerixafor. For arm B the stem cell collection will take place the day of administration starting 4 hours after the intravenous administration of plerixafor. Collection itself is a standard procedure and will take 4-5 hours. In case less than 2.0x106 CD34+cells/kg recipient body weight are collected the procedure (mobilization and collection) can be repeated the following day.

Donor follow-up will take place after 6 weeks, 6 months, 1 year and 2 years. Patient follow up will take place after 3, 6, 12, 18, 24 months.
- Main changes (audit trail)
- RECORD8-jun-2011 - 16-jun-2011


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