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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00342316




Registration number
NCT00342316
Ethics application status
Date submitted
20/06/2006
Date registered
21/06/2006
Date last updated
27/01/2020

Titles & IDs
Public title
Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia
Scientific title
Prospective Controlled Clinical Study of Allogeneic Stem Cell Transplantation With Reduced Conditioning (RICT) Versus Best Standard of Care in Acute Myeloid Leukemia (AML)in First Complete Remission (CR)
Secondary ID [1] 0 0
TRALG1/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Reduced Intensity Conditioning Stem Cell Transplantation

Experimental: Stem cell transplant (RICT) - Receiving intervention consisting of Reduced Intensity Conditioning Stem Cell Transplantation

No Intervention: Control arm - Treatment according to standard of care, i.e. not undergoing RICT


Treatment: Surgery: Reduced Intensity Conditioning Stem Cell Transplantation
One of the following conditioning regimens:
Busulphan (orally or IV), fludarabine
Fludarabine, carmustine, melfalan
Cyclophosphamide, fludarabine
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
From Inclusion until one of the above events (=2yrs in all surviving pts).
Secondary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
From Inclusion to relapse, death or study termination. Follow-up =24 mo in all surviving pts.
Secondary outcome [2] 0 0
Quality of Life for pts in the RICT and Control Groups.
Timepoint [2] 0 0
All pts were asked to fill out the instrument at 12 and 24 months after inclusion
Secondary outcome [3] 0 0
Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts
Timepoint [3] 0 0
From Inclusion to relapse or death until study termination.
Secondary outcome [4] 0 0
Acute and Chronic Graft-versus-Host Disease (GvHD)
Timepoint [4] 0 0
Acute GvHD: From transplant to 3 months. Chronic From transplantation to relapse, death or study termination

Eligibility
Key inclusion criteria
- Newly diagnosed patients with de novo or secondary AML

- Intermediate or poor risk

- In first complete remission

- Age 51-70 years

- Fit for the procedure

- Fit for further consolidation chemotherapy
Minimum age
51 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planned for a full-dose allogeneic transplant

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2018
Sample size
Target
Accrual to date
Final
340
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Austalasian Leukaemia &Lymphoma Group Limited - East Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Manitoba
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Canada
State/province [4] 0 0
Saskatchewan
Country [5] 0 0
Estonia
State/province [5] 0 0
Tartu
Country [6] 0 0
Finland
State/province [6] 0 0
Turku
Country [7] 0 0
Germany
State/province [7] 0 0
Freiburg
Country [8] 0 0
Greece
State/province [8] 0 0
Patras
Country [9] 0 0
New Zealand
State/province [9] 0 0
Christchurch
Country [10] 0 0
New Zealand
State/province [10] 0 0
Wellington
Country [11] 0 0
Norway
State/province [11] 0 0
Oslo
Country [12] 0 0
Sweden
State/province [12] 0 0
Goteborg
Country [13] 0 0
Sweden
State/province [13] 0 0
Luleå
Country [14] 0 0
Sweden
State/province [14] 0 0
Lund
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Sweden
State/province [16] 0 0
Uppsala
Country [17] 0 0
Sweden
State/province [17] 0 0
Örebro

Funding & Sponsors
Primary sponsor type
Other
Name
Vastra Gotaland Region
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Canadian Blood and Marrow Transplant Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australasian Leukaemia and Lymphoma Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study compares overall survival between patients with acute myeloid leukemia, who are in
complete remission following initial treatment with chemotherapy and whose remission is
maintained either with a transplantation of stem cells obtained from a sibling or unrelated
donor or with standard treatment, which is additional chemotherapy.

The study hypothesis is that the group transplanted with stem cells from a donor will have a
superior survival compared with patients treated with standard of care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00342316
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mats Brune, MD, PhD
Address 0 0
Göteborg University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries