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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001432
ACTR Number: ACTRN12606000303549
Trial Status: Registered
Date Submitted: 28/06/2006
Date Registered: 14/07/2006

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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.
ANZCTR registration 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:Australasian Leukaemia and Lymphoma Group (ALLG): ALLG BM08 
UTN:
Trial acronym:

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

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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:Treatment: Other 
Comparator / control treatment: No comparator.
Control group: Uncontrolled

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Primary outcome: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: 
Secondary outcome 1:To assess chimerism 
Timepoint:Chimerism will be measured at days 30, 60, 90, 180, 360, 540 and 730 post-transplantation. 
Secondary outcome 2:Graft vs host disease (GVHD) 
Timepoint:GVHD will be measured at the dates of diagnosis, histopathology and therapy with response and then on days 100, 180, 365. 
Secondary outcome 3:Toxicity and safety 
Timepoint:Toxicity and safety will be measured as clinically indicated. 
Secondary outcome 4:Disease free survival (DFS) and overall survival (OS) 
Timepoint:Disease free survival and overall survival will be measured at days 28, 100, 180, 365, 730 and other timepoints as clinically indicated. 

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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
Healthy volunteers? 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.

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Single group
Other design features (specify):
Type of endpoint(s): Safety/efficacy

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Phase Phase 2
Anticipated or actual date of first participant enrolement: 1/09/2006
Target sample size: 20
Recruitment status: Not yet recruiting

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Funding source:Commercial sector/Industry 
Name:Amgen Australia 
Address: 
Country:Australia 
Primary sponsor: Other Collaborative groups
Name: Australasian Leukaemia and Lymphoma Group
Address:
Country: Australia
Secondary sponsor:None 
Name:nil 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? No
Ethics Committee: 
Countries of recruitment:Australia 
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:
Presentations / publication list:

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Contact person for public queries
Name: Dr Ian Lewis
Address: Haematology/Oncology, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country: Australia
Tel: 08-8222 3328
Fax: 08-8222 3328
Email: ian.lewis@imvs.sa.gov.au

Contact person for scientific queries
Name: Dr Ian Lewis
Address: Haematology/Oncology Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country: Australia
Tel: 08-8222 3328
Fax: 08-8222 3328
Email: ian.lewis@imvs.sa.gov.au

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