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Trial registered on ANZCTR


Registration number
ACTRN12607000609459
Ethics application status
Approved
Date submitted
26/11/2007
Date registered
28/11/2007
Date last updated
17/07/2023
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Dasatinib plus Chemotherapy in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia
Scientific title
A Phase II Study of Dasatinib Combined with Induction Chemotherapy in Previously Untreated de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia to Assess Safety and Tolerability
Secondary ID [1] 298837 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ALL5
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Philadelphia Chromosone-Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) 2580 0
Condition category
Condition code
Cancer 2690 2690 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive a 7 day ‘pre-phase’ of dasatinib (70mg tablets, twice daily) prior to chemotherapy. Dasatinib will then be given at 50mg twice daily in combination with intensive chemotherapy using oral and intravenous drugs. Intensive chemotherapy consists of alternating courses of hyper-CVAD (cyclophosphamide, vincristine, Adriamycicn, and dexamethasone) with methotrexate plus cytarabine. Each course of dasatinib plus chemotherapy lasts 14 days and a maximum of 8 courses will be given.
Intervention code [1] 2314 0
Treatment: Drugs
Comparator / control treatment
No comparator/control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3600 0
Haematological toxicity. Measured as the incidence of prolonged myelosuppression.
Timepoint [1] 3600 0
Interim analysis after completion of dasatinib plus chemotherapy in first 8 patients; final analysis after 20 patients.
Primary outcome [2] 3601 0
The incidence of grade 3-4 non-haematological toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events) attributable to dasatinib.
Timepoint [2] 3601 0
Interim analysis after completion of dasatinib plus chemotherapy in first 8 patients; final analysis after 20 patients.
Secondary outcome [1] 6014 0
Response rate (haematological, cytogenetic and molecular)
Timepoint [1] 6014 0
Evaluated annually until 5 years post-registration
Secondary outcome [2] 6026 0
Disease-free survival
Timepoint [2] 6026 0
Evaluated annually until 5 years post-registration
Secondary outcome [3] 6027 0
Overall survival
Timepoint [3] 6027 0
Evaluated annually until 5 years post-registration

Eligibility
Key inclusion criteria
1.Patients aged between 16 and 70 years (inclusive)
2.Patients with a confirmed diagnosis of Ph+ ALL
3.Female patients of childbearing potential must have a negative pregnancy test, conducted within 7 days prior to registration.
4.Patient has given written informed consent.
5.Previously untreated with antineoplastic therapy for Ph+ ALL
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Exposure to any other investigational agents within 30 days of registration.
2.Known sensitivity to dasatinib
3.Eastern Cooperative Oncology Group (ECOG) performance status score > 2
4.Left ventricular ejection fraction < 50%
5.Creatinine >/= 1.5 x the upper limit of normal (ULN)
6.Serum bilirubin >/= 2 x ULN
7.AST or ALT > 2.5 x ULN
8.Known HIV or hepatitis B seropositivity
9.Pregnancy or breastfeeding
10. Prior diagnosis or evidence of chronic myeloid leukaemia (CML)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
7/11/2008
Date of last participant enrolment
Anticipated
Actual
27/04/2012
Date of last data collection
Anticipated
Actual
14/05/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,VIC,SA
Recruitment outside Australia
Country [1] 695 0
New Zealand
State/province [1] 695 0

Funding & Sponsors
Funding source category [1] 2824 0
Commercial sector/Industry
Name [1] 2824 0
Bristol-Myers Squibb Australia
Country [1] 2824 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group (ALLG)
Address
C- Centre for Biostatistics and Clinical Trials Peter MacCallum Cancer Centre
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 2551 0
None
Name [1] 2551 0
Address [1] 2551 0
Country [1] 2551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4760 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 4760 0
PO Royal Melbourne Hospital
Parkville VIC 3050
Ethics committee country [1] 4760 0
Australia
Date submitted for ethics approval [1] 4760 0
21/11/2007
Approval date [1] 4760 0
17/09/2008
Ethics approval number [1] 4760 0

Summary
Brief summary
This is a study of the drug Dasatinib combined with chemotherapy for treating people with acute lymphoblastic leukaemia (cancer of bone marrow and white blood cells) who also have the Philadelphia Chromosome.

Who is it for?
You can join this study if you:
- are aged 16–70 years
- have the Philadelphia Chromosome
- have acute lymphoblastic leukaemia which has not yet been treated.

Trial details:
All participants will receive Dasatinib tablets for 7 days prior to chemotherapy. Dasatinib will then be given at 50mg twice daily in combination with intensive chemotherapy using oral and intravenous drugs. Each course of Dasatinib plus chemotherapy lasts 14 days and a maximum of 8 courses will be given.

Dasatinib is used to reduce the risk of relapse by killing cells with mutations that might otherwise be resistant to the more commonly used drug in this situation, called imatinib. The trial aims to assess the effectiveness, safety and tolerability of Dasatinib plus chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28210 0
A/Prof Andrew Grigg
Address 28210 0
Royal Melbourne Hospital Grattan Street Parkville VIC 3050
Country 28210 0
Australia
Phone 28210 0
+61 3 93427690
Fax 28210 0
Email 28210 0
[email protected]
Contact person for public queries
Name 11367 0
Associate Professor Andrew Grigg
Address 11367 0
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 11367 0
Australia
Phone 11367 0
+61 3 93427690
Fax 11367 0
Email 11367 0
[email protected]
Contact person for scientific queries
Name 2295 0
Associate Professor Andrew Grigg
Address 2295 0
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 2295 0
Australia
Phone 2295 0
+61 3 93427690
Fax 2295 0
Email 2295 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified IPD data, for all data collected during the trial
When will data be available (start and end dates)?
Data available 3 months following publication, for an indefinite period
Available to whom?
Data are potentially available to:
• Researchers from not-for-profit organisations
• Commercial organisations
• Other
Based in:
• Any location
Further information:
All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health/). Search for the ACTRN number in the catalogue to find datasets associated with this trial or email enquiries to [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19712Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



Results publications and other study-related documents

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