None listed
Conditions
Brief summary
The use of umbilical cord blood (CB) as a source of haemopoietic stem cells (HSC) for transplantation is increasing. Advantages of using CB compared to other sources of HSC include a reduction in search time and procurement, a low risk of transmission of viral disease and a reduced incidence of graft versus host disease. Delayed engraftment, due to the low cell number in CB grafts, has emerged as the limiting factor to more widespread use of CB as a source of HSC. Transplantation of multiple CB units is one approach to overcome low cell numbers and preliminary results are encouraging. In this study, patients with high risk haematological malignancy who require a HSC transplant but do not have a related or unrelated donor will receive a double unit CB transplant. The study hypothesis is that transplantation of two cord blood units is feasible and safe to administer.
Interventions
Double Unit Cord Blood Transplantation in patients with high risk haematological malignancy in whom SCT offers the only prospect of cure.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 55 Years
Healthy volunteers
No
Inclusion criteria
1. H\Patients with high risk haematological malignancy in whom stem cell transplant offers the only prospect of cure, but do not have either a fully matched or one-antigen mismatched related donor or an identified suitable matched unrelated donor (URD).2. ECOG performance status 0-2. 3. Satisfactory major organ function- Cardiac function as measured by either a gated blood pool scan or echocardiogram showing left ventricular ejection fraction > 40%.- Pulmonary function as measured by a DLCO ³ 50% of normal.- Renal function as measured by a calculated or actual creatinine clearance > 30 ml/min.- Hepatic function as measured by a serum bilirubin greater than or equal to 30 micromol/l and transaminases greater than or equal to 2 x ULN. 4. Absence of severe uncontrolled infection. 5. Written informed consent given by recipient.
Exclusion criteria
1. Patients with a suitable matched related or unrelated donor in whom marrow or peripheral blood stem cells can be procured within a satisfactory time period.2. Patients who are positive for hepatitis B, hepatitis C or HIV.3. Pregnant or lactating women.4. No contraindication to use of any of the study drugs, including known sensitivity to E coli derived preparations.
Outcome results
None listed