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Trial registered on ANZCTR


Trial ID
ACTRN12605000460606
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II study of myeloablative allogeneic transplantation using pegylated G-CSF mobilised peripheral blood stem cells.
Scientific 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.
Universal Trial Number (UTN)
Trial acronym
BMT Neulasta
Linked study record

Health condition
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. 577 0
Condition category
Condition code
Blood 651 651 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
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 [1] 419 0
Prevention
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 771 0
Incidence of grades II-IV acute GVHD
Timepoint [1] 771 0
Day 100
Secondary outcome [1] 1563 0
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 [1] 1563 0
Secondary outcome [2] 1564 0
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 [2] 1564 0

Eligibility
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
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
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 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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] 716 0
Self funded/Unfunded
Name [1] 716 0
Address [1] 716 0
Country [1] 716 0
Primary sponsor type
Individual
Name
A/Prof Geoff Hill
Address
Country
Secondary sponsor category [1] 596 0
Hospital
Name [1] 596 0
Royal Brisbane and Women's Hospital
Address [1] 596 0
Country [1] 596 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1915 0
The Royal Brisbane and Women's Hospital.
Ethics committee address [1] 1915 0
Ethics committee country [1] 1915 0
Australia
Date submitted for ethics approval [1] 1915 0
Approval date [1] 1915 0
Ethics approval number [1] 1915 0
Ethics committee name [2] 1916 0
Westmead Hospital.
Ethics committee address [2] 1916 0
Ethics committee country [2] 1916 0
Australia
Date submitted for ethics approval [2] 1916 0
Approval date [2] 1916 0
Ethics approval number [2] 1916 0
Ethics committee name [3] 1917 0
The Royal Melbourne Hospital.
Ethics committee address [3] 1917 0
Ethics committee country [3] 1917 0
Australia
Date submitted for ethics approval [3] 1917 0
Approval date [3] 1917 0
Ethics approval number [3] 1917 0
Ethics committee name [4] 1918 0
The Alfred Hospital.
Ethics committee address [4] 1918 0
Ethics committee country [4] 1918 0
Australia
Date submitted for ethics approval [4] 1918 0
Approval date [4] 1918 0
Ethics approval number [4] 1918 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35430 0
Address 35430 0
Country 35430 0
Phone 35430 0
Fax 35430 0
Email 35430 0
Contact person for public queries
Name 9608 0
Ms Madonna Fuery
Address 9608 0
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 9608 0
Australia
Phone 9608 0
+61 7 36365750
Fax 9608 0
Email 9608 0
Madonna_Fuery@health.qld.gov.au
Contact person for scientific queries
Name 536 0
Associate Professor Geoff Hill
Address 536 0
The Queensland Institute of Medical Research
300 Herston Road
Brisbane QLD 4006
Country 536 0
Australia
Phone 536 0
+61 7 38453763
Fax 536 0
Email 536 0
geoffH@qimr.edu.au