The hypothesis to be tested is the feasibility of arm A and arm B.
ID
Bron
Verkorte titel
Aandoening
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)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2789 |
| NTR-old | NTR2929 |
| Ander register | HOVON : HO107 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |