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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: 000471
ACTR Number: ACTRN12605000460606
Trial Status: Registered
Date Submitted: 8/09/2005
Date Registered: 22/09/2005

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Public title: Phase II study of myeloablative allogeneic transplantation using pegylated G-CSF mobilised peripheral blood stem cells.
ANZCTR registration title: A Phase I/II trial to evaluate the effects of allogeneic pegylated G-CSF mobilized stem cells in the treatment of haematological malignancy to inhibit the incidence of GVHD.
Secondary ID: 
UTN:
Trial acronym: BMT Neulasta

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Health condition(s) or problem(s) studied:
Acute Graft Versus Host Disease following allogeneic peripheral blood stem cell transplant from am HLA identical sibling for a haematological malignancy. 
Condition category: Condition code:
Blood Haematological diseases 

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Description of intervention(s) / exposure: All donors will receive 12mg of pegylated G-CSF as a single dose sub-cutaneously 4 days prior to stem cell collection.
Intervention code:Prevention 
Comparator / control treatment:
Control group: Uncontrolled

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Primary outcome:Incidence of grades II-IV acute GVHD 
Timepoint:Day 100 
Secondary outcome 1:Donor endpoints: Incidence and severity of adverse events. Number of days with restriction of regular activities. Total CD34+ and CD3+ yield. Extended immunophenotyping of cellular content of peripheral blood stem cell product percentage + absolute CD3/4, CD3/8, CD4/25, CD13/33, CD16/56, CD5/19, DC subsets + CD11b/Gr-1 dim. 
Timepoint: 
Secondary outcome 2:Recipient endpoints: Engraftment: Time to ANC >500/l (first of 3 consecutive days). Time to platelet independence (first of 5 days unsupported > 20x109/l). Chimerism studies:Day +28, Day +100 and +6 months Treatment Response: Disease free survival and overall survival. Chronic GVHD: Incidence of limited and extensive chronic GVHD. Organ involvement by chronic GVHD. Duration of treatment for chronic GVHD. Immune reconstitution: Peripheral blood analysis pre-conditioning and Day +16, and months +1, +2, +3, +6, +12, +18,+24:T cell subsets (including T helper and cytotoxic subsets plus assessment of relative proportions of naiive and memory cells), B cells and NK cells. 3 colour FACS stains for CD3/4/8, CD5/19, CD16/56, CD4/25, CD3/45RA/45RO. Serum immunoglobulin levels monitored 3 monthly from Day 100 onward. 
Timepoint: 

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Key inclusion criteria: Diagnosis of haematological malignancy.Allogeneic peripheral blood stem cell transplant from an HLA identical sibling.Ablative conditioning regime (CY/TBI, BU/CY, FLU/MEL). ECOG performance status 0-2.Suitable HLA-identical sibling donor, fit for peripheral blood stem cell collection.
Minimum Age: Not stated
Maximum Age: 70 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: No exclusion criteria

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Study type: Interventional
Purpose of the study: Prevention
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 1 / Phase 2
Anticipated or actual date of first participant enrolement: 19/01/2004
Target sample size: 47
Recruitment status: Open to recruitment

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Funding source:Self funded/Unfunded 
Name: 
Address: 
Country: 
Primary sponsor: Individual
Name: A/Prof Geoff Hill
Address:
Country:
Secondary sponsor:Hospital 
Name:Royal Brisbane and Women's Hospital 
Address: 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:The Royal Brisbane and Women's Hospital. 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 2:Westmead Hospital. 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 3:The Royal Melbourne Hospital. 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Ethics Committee name 4:The Alfred Hospital. 
Address: 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Ms Madonna Fuery
Address: Cancer Care Clinical Trials Bone Marrow Transplantation (BMT) Department Royal Brisbane and Women's Hospital Level 5 Joyce Tweddell Building Butterfield Street Herston Brisbane QLD 4029
Country: Australia
Tel: +61 7 36365750
Fax:
Email: Madonna_Fuery@health.qld.gov.au

Contact person for scientific queries
Name: Associate Professor Geoff Hill
Address: The Queensland Institute of Medical Research 300 Herston Road Brisbane QLD 4006
Country: Australia
Tel: +61 7 38453763
Fax:
Email: geoffH@qimr.edu.au

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