Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000041651
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
25/07/2005
Date last updated
31/08/2023
Date data sharing statement initially provided
31/08/2023
Date results provided
31/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase II trial of Pegasys in Glivec responsive chronic phase chronic myeloid leukaemia
Scientific title
A phase II study of efficacy and safety of Pegasys in patients with Chronic Phase Chronic Myeloid Leukaemia in PCR+ve complete or near complete cytogenetic remission on Glivec at 600 mg daily or maximum tolerated dose
Secondary ID [1] 92 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG CML7
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic myeloid leukaemia 107 0
Condition category
Condition code
Cancer 126 126 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To establish whether the addition of the long activing interferon Pegasys is both safe and can improve molecular remission status in CML patients in good remission on Glivec.
Intervention code [1] 54 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 158 0
To assess whether adding interferon to imatinib in these patients improves molecular response status (by PCR quantification of bcr-abl transcripts)
Timepoint [1] 158 0
Measured in 18 months
Secondary outcome [1] 354 0
To assess the safety of treatment with interferon in such CML patients, who have had complete or near complete cytogenetic response to imatinib therapy.
Timepoint [1] 354 0
Outcome will be measured in 18 months.

Eligibility
Key inclusion criteria
All of the following criteria must be met: Cohort One: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved complete cytogenetic response on Glivec® therapy AND not previously in accelerated phase or blast crisis; 4. Sustained complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit for this study; 5. No past toxicity higher than Grade III related to high dose (>6MU/d) alpha- interferon therapy. No post toxicity higher than Grade II related to low dose (3MU/day or less) alpha-interferon therapy; 6. Persisting detectable bcr/abl transcripts by Q-PCR. 7. Patients must have adequate renal function i.e creatinine < 2 xULN 8. Adequate hepatic function, with serum bilirubin, AST and ALT each < 2 x the upper limit of their normal range (ULN) at the laboratory where the analyses were performed.
Cohort Two: 1. Chronic Myeloid Leukemia with Philadelphia chromosome translocation or bcr-abl transcript at diagnosis; 2. Treated with Glivec®, as a single agent at 600 mg or maximum tolerated dose for at least 6 months; 3. Achieved near complete cytogenetic response on Glivec® therapy OR Achieved a complete cytogenetic response on Glivec® therapy AND previously in accelerated phase or blast crisis; 4. Sustained complete or near-complete cytogenetic response for at least 6 months, confirmed by bone marrow studies at screening visit for this study; 5. No past toxicity higher than Grade III related to high dose (>6MU/d) alpha-interferon therapy. No post toxicity higher than Grade II related to low dose (3MU/day or less) alpha-interferon therapy; 6. Persisting detectable bcr/abl transcripts by Q-PCR. 7. Patients must have adequate renal function i.e creatinine < 2 xULN 8. Adequate hepatic function, with serum bilirubin, AST and ALT each < 2 x the upper limit of their normal range (ULN) at the laboratory where the analyses were performed;
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/07/2005
Actual
8/07/2005
Date of last participant enrolment
Anticipated
Actual
12/01/2007
Date of last data collection
Anticipated
Actual
12/01/2015
Sample size
Target
60
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 173 0
Commercial sector/Industry
Name [1] 173 0
Novartis Australia
Country [1] 173 0
Australia
Funding source category [2] 174 0
Commercial sector/Industry
Name [2] 174 0
Roche Australi
Country [2] 174 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
35 ELISABETH STREET VIC 3121
Country
Australia
Secondary sponsor category [1] 130 0
None
Name [1] 130 0
nil
Address [1] 130 0
Country [1] 130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 936 0
Mater Misericordiae Adult Hospital
Ethics committee address [1] 936 0
Ethics committee country [1] 936 0
Australia
Date submitted for ethics approval [1] 936 0
Approval date [1] 936 0
Ethics approval number [1] 936 0
Ethics committee name [2] 937 0
Mater Private Hospital
Ethics committee address [2] 937 0
Ethics committee country [2] 937 0
Australia
Date submitted for ethics approval [2] 937 0
02/04/2005
Approval date [2] 937 0
Ethics approval number [2] 937 0
Ethics committee name [3] 938 0
Royal North Shore
Ethics committee address [3] 938 0
Ethics committee country [3] 938 0
Australia
Date submitted for ethics approval [3] 938 0
Approval date [3] 938 0
29/03/2005
Ethics approval number [3] 938 0
Ethics committee name [4] 939 0
Albury Base Hospital
Ethics committee address [4] 939 0
Ethics committee country [4] 939 0
Australia
Date submitted for ethics approval [4] 939 0
Approval date [4] 939 0
16/02/2005
Ethics approval number [4] 939 0
Ethics committee name [5] 940 0
Murray Valley Private Hospital
Ethics committee address [5] 940 0
Ethics committee country [5] 940 0
Australia
Date submitted for ethics approval [5] 940 0
Approval date [5] 940 0
16/02/2005
Ethics approval number [5] 940 0
Ethics committee name [6] 941 0
Royal Brisbane Hospital
Ethics committee address [6] 941 0
Ethics committee country [6] 941 0
Australia
Date submitted for ethics approval [6] 941 0
21/02/2005
Approval date [6] 941 0
Ethics approval number [6] 941 0

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

Contacts
Principal investigator
Name 35352 0
Address 35352 0
Country 35352 0
Phone 35352 0
Fax 35352 0
Email 35352 0
Contact person for public queries
Name 9243 0
Dr Kerry Taylor
Address 9243 0
Haematology Department Mater Adult Hospital Level 6 Raymond Terrace South Brisbane QLD 4101
Country 9243 0
Australia
Phone 9243 0
+61 7 38408943
Fax 9243 0
+61 7 38408338
Email 9243 0
[email protected]
Contact person for scientific queries
Name 171 0
Dr Kerry Taylor
Address 171 0
Haematology Department Mater Adult Hospital Level 6 Raymond Terrace South Brisbane QLD 4101
Country 171 0
Australia
Phone 171 0
+61 7 38408943
Fax 171 0
+61 7 38408338
Email 171 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• 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 sponsor ALLG 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.


Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified IPD data for all data collected during the trial

What types of analyses could be done with individual participant data?
• Any type of analysis. Proposals will be assessed on a case-by-case basis

When can requests for individual participant data be made (start and end dates)?
From:
Data available 3 months following publication, for an indefinite period

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20196Study protocol  [email protected] Access can be requested via the Health Data Austra... [More Details]



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.