The hypothesis to be tested is the feasibility of arm A and arm B.
Verkorte titel
Health condition
Stem cell mobilization in healthy HLA- matched adult sibling donors with plerixafor. Patients diagnosed with Leukemia/myelodysplasia eligible for allogeneic stem cell transplantation
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. box 5201
3008 AE Rotterdam
Tel: +31 10 7041560
Fax: +31 10 7041028
e-mail: hdc@erasmusmc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.<br>
Feasibilty is defined as a minimum of 2.0x106/kg CD34+ cells in one or two phereses in at least 90% of the donors.
Achtergrond van het onderzoek
Study 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.
Doel van het onderzoek
The hypothesis to be tested is the feasibility of arm A and arm B.
Onderzoeksopzet
Donor:
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.
Onderzoeksproduct en/of interventie
Arm A: Donors will receive plerixafor 320 μg/kg subcutaneously;
Arm B: Donors will receive plerixafor 320 μg/kg intravenously.
Publiek
Erasmus MC - Daniel den Hoed<br>
P.O. box 5201
G.E. Greef, de
Rotterdam 3008 AE
The Netherlands
+31 (0)10 7041367
g.degreef@erasmusmc.nl
Wetenschappelijk
Erasmus MC - Daniel den Hoed<br>
P.O. box 5201
G.E. Greef, de
Rotterdam 3008 AE
The Netherlands
+31 (0)10 7041367
g.degreef@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Donors:
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Donors:
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
In dit register bekende (historische) registraties
Geen registraties gevonden
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2789 |
| NTR-old | NTR2929 |
| Ander register | HOVON : HO107 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |