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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00342316
Ethics application status
Date submitted
20/06/2006
Date registered
21/06/2006

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:

1. Busulphan (orally or IV), fludarabine
2. Fludarabine, carmustine, melfalan
3. Cyclophosphamide, fludarabine
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Assessment method [1] 0 0
OS is the time from Inclusion to death, lost to follow-up, refusal, or study termination.
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
Assessment method [1] 0 0
DFS is the time from Inclusion until date of first documented relapse, death from any cause whichever came first, assessed until study termination.
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.
Assessment method [2] 0 0
European Organization for Research and Treatment of Cancer (EORTC). Quality of Life Questionnaire (QLQ), Cancer C) #30. An instrument commonly used for the evaluation of QoL after under and after cancer treatment
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
Assessment method [3] 0 0
NRM is death without preceding relapse, from Inclusion to study termination.
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)
Assessment method [4] 0 0
In transplanted pts only. Acute GvHD appears from transplant to 100 days. Chronic GvHD occurs later, and often remains for years. Both are clinical diagnoses and cGvHD grading were performed annually until death or study termination.
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
Government body
Name
Vastra Gotaland Region
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Canadian Blood and Marrow Transplant Group
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australasian Leukaemia and Lymphoma Group
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00342316