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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00766779




Registration number
NCT00766779
Ethics application status
Date submitted
3/10/2008
Date registered
6/10/2008
Date last updated
31/08/2017

Titles & IDs
Public title
HCT Versus CT in Elderly AML
Scientific title
Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission
Secondary ID [1] 0 0
EBMT-ALWP01/2008
Secondary ID [2] 0 0
2007-003514-34
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 - hematopoietic cell transplantation
Treatment: Drugs - Non-Transplant treatment approach for consolidation

Experimental: Transplant Arm - Hematopoietic cell transplantation after Reduced Intensity Conditioning

Active Comparator: Conventional Chemotherapy - The non-transplant treatment approach for consolidation


Treatment: Surgery: hematopoietic cell transplantation
low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors

Treatment: Drugs: Non-Transplant treatment approach for consolidation
Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.

Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
Timepoint [1] 0 0
5 Years

Eligibility
Key inclusion criteria
- Age = 60years and = 75 years

- primary or secondary AML as defined by WHO or refractory anemia with excess of blasts
(RAEB)

- First complete remission following one or two cycles of induction chemotherapy

- Chemotherapy was administered according to current participating cooperative group
protocols

- Karnofsky score = 70

- Written informed consent
Minimum age
60 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- AML FAB M3

- HIV positivity

- Participation in another clinical trial without prior consent of the coordinating
investigator, patients may exceptionally take part in a further study only if

- The second study exclusively concerns induction therapy

- Consolidation cycle one and two are given according to the accredited study group
policy

- No investigational drugs are used post registration for the HCT vs CT in eldery
AML study.

- Documentation for the HCT vs CT in eldery AML study is not compromised. Second
hand data from foreign study is not accepted

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
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne Victoria
Recruitment postcode(s) [1] 0 0
- Melbourne Victoria
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
France
State/province [4] 0 0
Amiens cedex 1
Country [5] 0 0
France
State/province [5] 0 0
Caen Cedex 9
Country [6] 0 0
France
State/province [6] 0 0
Clamart
Country [7] 0 0
France
State/province [7] 0 0
Clermont-Ferrand
Country [8] 0 0
France
State/province [8] 0 0
Limoges cedex
Country [9] 0 0
France
State/province [9] 0 0
Marseille cedex 9
Country [10] 0 0
France
State/province [10] 0 0
Nantes cedex 01
Country [11] 0 0
France
State/province [11] 0 0
Nice cedex 2
Country [12] 0 0
France
State/province [12] 0 0
Nice
Country [13] 0 0
France
State/province [13] 0 0
PARIS 12ème
Country [14] 0 0
France
State/province [14] 0 0
Pessac
Country [15] 0 0
France
State/province [15] 0 0
Saint Quentin cedex
Country [16] 0 0
Germany
State/province [16] 0 0
Aachen
Country [17] 0 0
Germany
State/province [17] 0 0
Augsburg
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Chemnitz
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Greifswald
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Germany
State/province [23] 0 0
Jena
Country [24] 0 0
Germany
State/province [24] 0 0
Leipzig
Country [25] 0 0
Germany
State/province [25] 0 0
Magdeburg
Country [26] 0 0
Germany
State/province [26] 0 0
Münster
Country [27] 0 0
Germany
State/province [27] 0 0
Potsdam
Country [28] 0 0
Germany
State/province [28] 0 0
Regensburg
Country [29] 0 0
Germany
State/province [29] 0 0
Rostock
Country [30] 0 0
Germany
State/province [30] 0 0
Stuttgart
Country [31] 0 0
Germany
State/province [31] 0 0
Tübingen
Country [32] 0 0
Germany
State/province [32] 0 0
Würzburg
Country [33] 0 0
Netherlands
State/province [33] 0 0
Amsterdam
Country [34] 0 0
Netherlands
State/province [34] 0 0
Groningen
Country [35] 0 0
Netherlands
State/province [35] 0 0
Maastricht
Country [36] 0 0
Netherlands
State/province [36] 0 0
Rotterdam
Country [37] 0 0
Netherlands
State/province [37] 0 0
Utrecht
Country [38] 0 0
Netherlands
State/province [38] 0 0
Zwolle
Country [39] 0 0
Switzerland
State/province [39] 0 0
Aarau
Country [40] 0 0
Switzerland
State/province [40] 0 0
Basel
Country [41] 0 0
Switzerland
State/province [41] 0 0
Bern
Country [42] 0 0
Switzerland
State/province [42] 0 0
Geneve
Country [43] 0 0
Switzerland
State/province [43] 0 0
Lausanne
Country [44] 0 0
Switzerland
State/province [44] 0 0
Luzern 16
Country [45] 0 0
Switzerland
State/province [45] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
EBMT
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Acute Leukemia French Association
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
European Organisation for Research and Treatment of Cancer - EORTC
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
French Innovative Leukemia Organisation
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
HOVON - Dutch Haemato-Oncology Association
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
East German Study Group of Hematology and Oncology (OSHO)
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Swiss Group for Clinical Cancer Research
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A study comparing conventional chemotherapy to low dose total body irradiation-based
conditioning and hematopoietic cell transplantation from related and unrelated donors as
consolidation therapy for older Patients with AML in first Complete Remission.
Trial website
https://clinicaltrials.gov/show/NCT00766779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dietger Niederwieser, Prof
Address 0 0
EBMT and OSHO
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00766779