Trial registered on ANZCTR


Trial ID
ACTRN12606000303549
Ethics application status
Not yet submitted
Date submitted
28/06/2006
Date registered
14/07/2006
Date last updated
29/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of engraftment kinetics following double unit umbilical cord blood transplantation in patients with life threatening haematological malignancy in whom stem cell transplant (SCT) offers the only prospect of cure.
Scientific title
Evaluation of engraftment kinetics following double unit umbilical cord blood transplantation in patients with life threatening haematological malignancy in whom stem cell transplant (SCT) offers the only prospect of cure.
Secondary ID [1] 280 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG BM08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk haematological malignancy 1276 0
Condition category
Condition code
Blood 1363 1363 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double Unit Cord Blood Transplantation in patients with high risk haematological malignancy in whom SCT offers the only prospect of cure.
Intervention code [1] 1177 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1857 0
To estimate the time to neutrophil and platelet engraftment of double unit unrelated cord blood transplantation in adult patients with high risk malignancy. Specifically, to analyse the ability of a two unit cord blood transplant with Filgrastim support to achieve timely engraftment.
Timepoint [1] 1857 0
Secondary outcome [1] 3275 0
To assess chimerism
Timepoint [1] 3275 0
Chimerism will be measured at days 30, 60, 90, 180, 360, 540 and 730 post-transplantation.
Secondary outcome [2] 3276 0
Graft vs host disease (GVHD)
Timepoint [2] 3276 0
GVHD will be measured at the dates of diagnosis, histopathology and therapy with response and then on days 100, 180, 365.
Secondary outcome [3] 3277 0
Toxicity and safety
Timepoint [3] 3277 0
Toxicity and safety will be measured as clinically indicated.
Secondary outcome [4] 3278 0
Disease free survival (DFS) and overall survival (OS)
Timepoint [4] 3278 0
Disease free survival and overall survival will be measured at days 28, 100, 180, 365, 730 and other timepoints as clinically indicated.

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1497 0
Commercial sector/Industry
Name [1] 1497 0
Amgen Australia
Address [1] 1497 0
Country [1] 1497 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 1315 0
None
Name [1] 1315 0
nil
Address [1] 1315 0
Country [1] 1315 0

Ethics approval
Ethics application status
Not yet submitted

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35591 0
Address 35591 0
Country 35591 0
Phone 35591 0
Fax 35591 0
Email 35591 0
Contact person for public queries
Name 10366 0
Dr Ian Lewis
Address 10366 0
Haematology/Oncology, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 10366 0
Australia
Phone 10366 0
08-8222 3328
Fax 10366 0
08-8222 3328
Email 10366 0
ian.lewis@imvs.sa.gov.au
Contact person for scientific queries
Name 1294 0
Dr Ian Lewis
Address 1294 0
Haematology/Oncology Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 1294 0
Australia
Phone 1294 0
08-8222 3328
Fax 1294 0
08-8222 3328
Email 1294 0
ian.lewis@imvs.sa.gov.au