Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000505202
Ethics application status
Approved
Date submitted
15/03/2018
Date registered
6/04/2018
Date last updated
21/07/2024
Date data sharing statement initially provided
13/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of using Cyclophosphamide After Sibling-donor allogeneic stem-cell Transplantation (CAST) in patients with acute leukaemia and myelodysplasia
Scientific title
Study of using Cyclophosphamide After Sibling-donor allogeneic stem-cell Transplantation (CAST) in patients with acute leukaemia and myelodysplasia: a randomised study comparing cyclosporin and methotrexate to cyclosporin and post-transplantation cyclophosphamide for graft-versus-host disease prophylaxis.
Secondary ID [1] 294348 0
ALLG BM12
Universal Trial Number (UTN)
Trial acronym
CAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Leukaemias 307071 0
Myelodysplasia 307129 0
Condition category
Condition code
Blood 306178 306178 0 0
Haematological diseases
Cancer 306240 306240 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GVHD prophylaxis consists of post-transplant iv cyclophosphamide 50 mg/kg on Day +3, +4 and oral cyclosporin commencing on Day +5, Cyclosporin lasts 90 days
Cyclosporin dosing is as per institution’s standard practice. The protocol recommends maintaining trough cyclosporin level at > 140 µg/l in the absence of toxicity
Intervention code [1] 300650 0
Treatment: Drugs
Comparator / control treatment
The GVHD prophylaxis consists of oral cyclosporin starting from day -1 and iv methotrexate 15 mg/m2 day +1 and 10 mg/m2 on days +3, +6 and +11.
Cyclosporin lasts 90 days
Cyclosporin dosing is as per institution’s standard practice. The protocol recommends maintaining trough cyclosporin level at > 140 µg/l in the absence of toxicity
Control group
Active

Outcomes
Primary outcome [1] 305188 0
Graft versus host disease and relapse free survival (GRFS) - composite endpoint

GVHD-free/relapse-free survival (GRFS) is measured from the date of allogeneic HSCT to the earliest occurrence of any of the following events: grade 3-4 acute GVHD, NIH moderate or severe chronic GVHD, disease relapse or death from any cause.
Timepoint [1] 305188 0
24 months post transplant
Secondary outcome [1] 344457 0
Non relapse mortality

Death without prior relapse of disease. All survival times measured from the date of HSCT.
Timepoint [1] 344457 0
12 and 24 months post transplant
Secondary outcome [2] 344876 0
Health related QoL
1. The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire includes 27 items assessing 4 aspects of well-being (physical, functional, emotional, social/family), plus 23 symptoms and issues specific to bone marrow transplant. The FACT-BMT is valid responsive to change over and well-suited to this trial due to the clinical relevance of scale items. It will also enable calculation of the FACT-8D utility scores

2. The FACT-Fatigue includes 13 items assessing symptoms and consequences of fatigue. It has been validated in a cancer population.

3. The Physical functioning sub-scale of the EORTC QLQ-C30, which contains 5 items, will be used to supplement the physical wellbeing scale of the FACT-BMT, to obtain a clearer estimate of the impact of the disease and treatment on mobility and self-care issues. It adds 13 items to the PRO assessment battery.

4. The EQ-5D-5L is a preference-based measure of QoL that will be used to estimate health utilities scores and combined with survival endpoints to calculate quality-adjusted life years for incorporation in health economic analyses.

5. The COST-FACIT (version 1) includes 11 items assessing patients’ perceptions of their financial situation and the financial burden of their disease and treatment.

HRQoL is a single secondary outcome, measured using multiple instruments
Timepoint [2] 344876 0
12 and 24 months post-transplant

Eligibility
Key inclusion criteria
• 18-70 years of age
• Adult patients with AML/ALL in remission or MDS with <20% myeloblasts
• Availability of 6/6-matched sibling donor
• Adequate cardiac (LVEF greater than or equal to 40%), pulmonary (DLCO/VA >50%) and renal function (Creatinine Clearance greater than or equal to 60 ml/min).
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Donor other than a sibling
• Graft source other than G-CSF mobilised PBSC
• Use of in-vitro or in-vivo T-cell depletion
• Life expectancy from co-morbid medical conditioning less than 12 months
• Uncontrolled infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2018
Actual
4/04/2019
Date of last participant enrolment
Anticipated
30/10/2023
Actual
30/01/2024
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
134
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 13986 0
The Alfred - Prahran
Recruitment hospital [2] 13987 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 13988 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 13989 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 13990 0
Westmead Private Hospital - Westmead
Recruitment hospital [6] 16792 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [7] 16793 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [8] 26821 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 26764 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 26765 0
3004 - Prahran
Recruitment postcode(s) [3] 26766 0
5000 - Adelaide
Recruitment postcode(s) [4] 26767 0
6150 - Murdoch
Recruitment postcode(s) [5] 26768 0
2145 - Westmead
Recruitment postcode(s) [6] 30415 0
3084 - Heidelberg
Recruitment postcode(s) [7] 30416 0
4029 - Herston
Recruitment postcode(s) [8] 42871 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 24947 0
New Zealand
State/province [1] 24947 0
Auckland
Country [2] 24948 0
New Zealand
State/province [2] 24948 0
Wellington

Funding & Sponsors
Funding source category [1] 298991 0
Government body
Name [1] 298991 0
NHMRC
Country [1] 298991 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Leukaemia and Lymphoma Group
Address
Ground Floor, 35 Elizabeth St
Richmond, VIC 3121
Country
Australia
Secondary sponsor category [1] 298217 0
None
Name [1] 298217 0
Address [1] 298217 0
Country [1] 298217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299920 0
Alfred Health Ethics Committee
Ethics committee address [1] 299920 0
Ethics committee country [1] 299920 0
Australia
Date submitted for ethics approval [1] 299920 0
23/04/2018
Approval date [1] 299920 0
22/10/2018
Ethics approval number [1] 299920 0

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

Contacts
Principal investigator
Name 81990 0
Dr Sushrut Patil
Address 81990 0
Level 1, Alfred Centre - Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 81990 0
Australia
Phone 81990 0
+61 3 9903 0225
Fax 81990 0
Email 81990 0
[email protected]
Contact person for public queries
Name 81991 0
David Curtis
Address 81991 0
Level 1, Alfred Centre - Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 81991 0
Australia
Phone 81991 0
+61 3 9903 0225
Fax 81991 0
Email 81991 0
[email protected]
Contact person for scientific queries
Name 81992 0
David Curtis
Address 81992 0
Level 1, Alfred Centre - Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 81992 0
Australia
Phone 81992 0
+61 3 9903 0225
Fax 81992 0
Email 81992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be publicly available as it is the aggregate data that is under investigation.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.