None listed
Conditions
Brief summary
This study aims to evaluate the effect of haploidentical donor stem cell transplantation in patients with haematological malignancies. Who is it for? You may be eligible to join this study if you are aged between 16-50 years and have ongoing complete remission of underlying haematological malignancy. You should have available a haploidentical family donor. This is a donor who is a 50% match, and can be a parent, sibling or child. Trial details All participants in this trial will undergo ten days of chemotherapy treatment, followed by infusion of peripheral blood stem cells (PBSCs) from the donor into the vein (i.e. intravenously). Participants will also be administered a number of medications to prevent graft versus host disease (GVHD), which is a common complication following stem cell transplantation. Patients will be regularly assessed for up to 12 months in order to evaluate clinical efficacy and safety of treatment.
Interventions
Patients are given Peripheral blood stem cells (PBSCs) collected from a haploidentical family member after completing myeloablative chemotherapy.
The myeloablative chemotherapy consists of the following:
* Cytosine arabinoside 2g/m^2 twice daily by intravenous infusion on Days -10 & -9
* Busulfan 3.2mg/kg/day by intravenous infusion on Days -8 to -6 (Pharmacokinetically monitored and adjusted to target AUC 4500micrometre/min)
* Cyclophosphamide 1.8g/m^2/day by intravenous infusion on days -
Patients are given Peripheral blood stem cells (PBSCs) collected from a haploidentical family member after completing myeloablative chemotherapy. The myeloablative chemotherapy consists of the following: * Cytosine arabinoside 2g/m^2 twice daily by intravenous infusion on Days -10 & -9 * Busulfan 3.2mg/kg/day by intravenous infusion on Days -8 to -6 (Pharmacokinetically monitored and adjusted to target AUC 4500micrometre/min) * Cyclophosphamide 1.8g/m^2/day by intravenous infusion on days -5 & -4 * CCNU (Lomustine) 200mg/m^2 by oral administration on Day -3 only * ATG (thymoglobuline) 2.5mg/kg/day by intravenous infusion on Days -5 to -2 On day 0 participants then undergo infusion of unmanipulated GCSF primed bone marrow harvest +/PBSC supplementation (on second day 0) to achieve MNC & CD34 minimum thresholds (>4.0x10^8/kg & >2.0x10^6/kg respectively). All participants will also undergo a GVHD prophylaxis regimen, which consists of: * Cyclosporin 2.5mg/kg/day initially by intravenous infusion thence orally once tolerated from Day -9; At day +45 cyclosporin taper should be commenced (unless active GVHD) ~10% per month * Mycophenolate 0.5g orally twice daily from Day -9; to be ceased on day +60 (unless active GVHD) * Methotrexate 15mg/m^2 by intravenous infusion on Day +1 * Methotrexate 10mg/m^2 by intravenous infusion on Days +3,+6,+11 * GCSF 5mcg/kg subcutaneously daily until neutrophil recovery of >2.0x10^9/L for at least 2 days.
Sponsors
St Vincent's Hospital,Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
ongoing complete remission of underlying haematological malignancy Absence of a 100% matched or single-mismatch related donor or single umbilical cord blood with 4/6 HLA match. Presence of 1 haploidentical famiy donor Absence of active fungalor viral (inc CMV) infection. ECOG<2 Preserved cardiac/renal/liver function
Exclusion criteria
Life expectance <3 months. Psychiatric condition interfering with informed consent. History of active malignant disease within 5 yrs excl SCC or BCC of skin. Previuos allogeneic stem cell transplant Taking other 'investigational' drugs
Outcome results
None listed