Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000575831
Ethics application status
Approved
Date submitted
19/05/2012
Date registered
29/05/2012
Date last updated
29/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reduced intensity conditioning stem cell transplantation for lymphoid and myeloid malignancies in Australia and New Zealand
Scientific title
Fludarabine Melphalan Conditioning provides similar disease control in both Lymphoid and Myeloid Malignancies – A retrospective analysis of 344 patients by the Australasian Bone Marrow Transplant Recipient Registry (ABMTRR)
Secondary ID [1] 280357 0
nil
Universal Trial Number (UTN)
U1111-1130-0564
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute myeloid leukemia 286324 0
myelodysplastic syndrome 286325 0
non Hodgkins lymphoma 286326 0
chronic lymphocytic leukemia 286327 0
myelofibrosis 286328 0
Hodgkin's lymphoma 286329 0
acute biphenotypic leukemia 286330 0
Condition category
Condition code
Cancer 286571 286571 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 286572 286572 0 0
Leukaemia - Acute leukaemia
Cancer 286573 286573 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This was a multi-centre retrospective analysis of the Australia and New Zealand experience with reduced intensity conditioning using Fludarabine and Melphalan. Haematopoietic stem cell transplant recipients (HSCT) were selected from the Australian Bone Marrow Transplant Registry. All eligible fludarabine melphalan (i.e. reduced intensity) conditioned HSCTs performed in the participating centres between January 1998 to December 2008 were to be included for evaluation.
Intervention code [1] 284723 0
Not applicable
Comparator / control treatment
no comparator; this is a retrospective registry study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286997 0
Overall survival at 3 years post HSCT was analysed using Kaplan-Meier survival curves and multivariate Cox regression analysis.
Timepoint [1] 286997 0
This information is determined as part as required reporting information at the Australasian Bone Marrow Transplants recipient registry. Where ambiguity exists, information was confirmed with direct medical record review. Statistical analysis was performed at the close out date of the study 31 December 2010.
Primary outcome [2] 286998 0
Disease free survival post HSCT.
1, 2 and 3 years post HSCT.

This was measured retrospectively using database information from the individual participating units.
Timepoint [2] 286998 0
1, 2 and 3 years post HSCT

This information is determined as part as required reporting information at the Australasian Bone Marrow Transplants recipient registry. Where ambiguity exists, information was confirmed with direct medical record review. Statistical analysis was performed at the close out date of the study 31 December 2010.
Secondary outcome [1] 297169 0
Time to platelet and neutrophils engraftment
Timepoint [1] 297169 0
Day of neutrophil engraftment was defined as the first of 3 consecutive days of a blood neutrophil count of 0.5 x 109/L or above.

Day of platelet engraftment was defined as the first day when the blood platelet count was 20 x 109/L or above and there had been no platelet transfusions in the previous 7 days.
Secondary outcome [2] 297170 0
Transplant related mortality

Deaths attributable to stem cell transplant and conditioning (ie not relapse or progressive disease).
Timepoint [2] 297170 0
The patients will be coded as surviving (or not) to 100 days and 1 year post transplantation.

This information is determined as part as required reporting information at the Australasian Bone Marrow Transplants recipient registry. Where ambiguity exists, information was confirmed with direct medical record review. Statistical analysis was performed at the close out date of the study 31 December 2010.
Secondary outcome [3] 297171 0
Acute graft versus host disease: Incidence within 100 days of transplantation.

This refers to graft versus host disease of the liver, skin or gastrointestinal tract occurring within 100 days of HSCT.
Timepoint [3] 297171 0
This information is determined as part as required reporting information at the Australasian Bone Marrow Transplants recipient registry. Where ambiguity exists, information was confirmed with direct medical record review. Statistical analysis was performed at the close out date of the study 31 December 2010.
Secondary outcome [4] 297172 0
Chronic graft versus host disease.

This refers to graft versus host disease occurring great than 100 days from the date of transplantation
Timepoint [4] 297172 0
This information is determined as part as required reporting information at the Australasian Bone Marrow Transplants recipient registry. Where ambiguity exists, information was confirmed with direct medical record review. Statistical analysis was performed at the close out date of the study 31 December 2010.
Secondary outcome [5] 297173 0
Disease Relapse.
Timepoint [5] 297173 0
This information is determined as part as required reporting information at the Australasian Bone Marrow Transplants recipient registry. Where ambiguity exists, information was confirmed with direct medical record review. Statistical analysis was performed at the close out date of the study 31 December 2010.

Eligibility
Key inclusion criteria
first allogeneic peripheral blood or bone marrow HSCT using Fludarabine Melphalan conditioning for lymphoid and myeloid malignancies between January 1998 and December 2008
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
multiple myeloma
acute lymphoblastic leukemia
prior allogeneic HSCT

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5311 0
2010
Recruitment outside Australia
Country [1] 4271 0
New Zealand
State/province [1] 4271 0

Funding & Sponsors
Funding source category [1] 285135 0
Self funded/Unfunded
Name [1] 285135 0
Country [1] 285135 0
Primary sponsor type
Other Collaborative groups
Name
Australian Bone Marrow Transplant Recipient Registry
Address
16 Leichhardt Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 284000 0
None
Name [1] 284000 0
Address [1] 284000 0
Country [1] 284000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287150 0
St Vincents Hospital (Sydney) Human Research Ethics Committee
Ethics committee address [1] 287150 0
St Vincent's Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 287150 0
Australia
Date submitted for ethics approval [1] 287150 0
Approval date [1] 287150 0
23/08/2005
Ethics approval number [1] 287150 0
1/05/0054

Summary
Brief summary
Allogeneic haemopoietic stem cell transplantation (HSCT) is a potentially curative procedure for a wide range of haematological malignancies, but the benefit of the graft versus malignancy effect is often offset by increased toxicity of graft versus host disease (GVHD) and infection. Reduced intensity conditioning (RIC) regimens have become more commonly used over the last 10 years in HSCT in an attempt to provide the potential curative benefit of allografting to a wider patient population. Most published literature on RIC transplantation has concentrated on one disease and the relative benefit of a particular form of RIC conditioning in that disease setting. There have been few studies analyzing a commonly used regimen and assessing its benefit across several disease groups. Indeed, there is no consensus on the relative benefits of a certain RIC regimen even in myeloid or lymphoid malignancies as a general group of diseases. In this study, we retrospectively assess the relative benefits of FluMel RIC HSCT from 1998-2008, in a large cohort of patients with either lymphoid or myeloid malignancies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34089 0
Address 34089 0
Country 34089 0
Phone 34089 0
Fax 34089 0
Email 34089 0
Contact person for public queries
Name 17336 0
Dr John Moore
Address 17336 0
St Vincent's Hospital
Darlinghurst (Sydney)
NSW 2010
Australia
Country 17336 0
Australia
Phone 17336 0
+61 2 8382 1111
Fax 17336 0
+61 2 8382 2645
Email 17336 0
jmoore@stvincents.com.au
Contact person for scientific queries
Name 8264 0
Dr John Moore
Address 8264 0
St Vincent's Hospital
Darlinghurst (Sydney)
NSW 2010
Australia
Country 8264 0
Australia
Phone 8264 0
+61 2 8382 1111
Fax 8264 0
+61 2 8382 2645
Email 8264 0
jmoore@stvincents.com.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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