Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000071628
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
4/08/2005
Date last updated
29/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot cml autograft/glivec (STI571)/Intron A trial
Scientific title
Pilot study to determine the efficacy and safety of Glivec (STI571) alone and Glivec (STI571) plus Intron A in the early recovery phase post autologous blood or marrow transplant for advanced phase chronic myeloid leukaemia and Ph-positive acute lymphoblastic leukemia
Secondary ID [1] 97 0
Australasian Leukaemia and Lymphoma Group (ALLG): ALLG CML4
Secondary ID [2] 98 0
National Clinical Trials Registry: NCTR526
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced phase chronic myeloid leukaemia 143 0
Ph-positive acute lymphoblastic leukemia 144 0
Condition category
Condition code
Cancer 163 163 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates the addition of Glivec (Imatinib) at variable time points in the first weeks to months post autologous stem cell transplant to evaluate safety and efficacy in the treatment of Philadelphia chromosome positive leukemia.
Intervention code [1] 111 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 204 0
To assess the safety of Glivec introduced early in the recovery phase post autograft.
Timepoint [1] 204 0
Assessed in the first 1-3 months post initiation of therapy and then longer term assessment at 3,6,9,12 months post transplant and then long term follow up for as long as patients remain in study treatment.
Secondary outcome [1] 464 0
Timepoint [1] 464 0

Eligibility
Key inclusion criteria
1. Patients considered eligible for autologous transplantation by local institutional criteria. 2. Patients with a confirmed diagnosis of Ph chromosome-positive CML not in first chronic phase or Ph chromosome-positive ALL (or patients who are Ph chromosome-negative but BCR/ABL-positive). Patients with chronic phase Ph+ CML with development of resistance to Glivec will also be eligible. Patients with chronic phase CML who are primarily resistant to Glivec will also be eligible. 3. Cryopreserved autologous bone marrow or peripheral blood cells available which contain >2 x 106/L CD34+ cells or an equivalent number of CFU-GM/kg by local institutional criteria. 4. AST (SGOT) and ALT (SGPT) less than or equal to 3x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed. In patients with clinically suspected leukaemic involvement of the liver, AST and ALT less than or equal to 5x the ULN. 5. Total serum bilirubin level less than or equal to 3x the ULN at the laboratory where the analysis was performed. 6. Serum creatinine less than or equal to 1.5 x the upper limit of normal 7. Patients of childbearing potential must have a negative pregnancy test prior to the initiation of study drug. Patients will need to use barrier contraceptive measures throughout the trial 8. Written voluntary informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No 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)
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 216 0
Commercial sector/Industry
Name [1] 216 0
Novartis Australia
Country [1] 216 0
Australia
Funding source category [2] 217 0
Commercial sector/Industry
Name [2] 217 0
Amgen Australia
Country [2] 217 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Country
Australia
Secondary sponsor category [1] 163 0
None
Name [1] 163 0
nil
Address [1] 163 0
Country [1] 163 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 992 0
Royal Adelaide
Ethics committee address [1] 992 0
Ethics committee country [1] 992 0
Australia
Date submitted for ethics approval [1] 992 0
Approval date [1] 992 0
Ethics approval number [1] 992 0
Ethics committee name [2] 993 0
Canberra
Ethics committee address [2] 993 0
Ethics committee country [2] 993 0
Australia
Date submitted for ethics approval [2] 993 0
Approval date [2] 993 0
Ethics approval number [2] 993 0
Ethics committee name [3] 994 0
Launceston
Ethics committee address [3] 994 0
Ethics committee country [3] 994 0
Australia
Date submitted for ethics approval [3] 994 0
Approval date [3] 994 0
Ethics approval number [3] 994 0
Ethics committee name [4] 995 0
Mater Brisbane
Ethics committee address [4] 995 0
Ethics committee country [4] 995 0
Australia
Date submitted for ethics approval [4] 995 0
Approval date [4] 995 0
Ethics approval number [4] 995 0
Ethics committee name [5] 996 0
Mater Private Med Centre
Ethics committee address [5] 996 0
Ethics committee country [5] 996 0
Australia
Date submitted for ethics approval [5] 996 0
Approval date [5] 996 0
Ethics approval number [5] 996 0
Ethics committee name [6] 997 0
Peter MacCallum Cancer Centre
Ethics committee address [6] 997 0
Ethics committee country [6] 997 0
Australia
Date submitted for ethics approval [6] 997 0
Approval date [6] 997 0
Ethics approval number [6] 997 0
Ethics committee name [7] 998 0
Prince of Wales
Ethics committee address [7] 998 0
Ethics committee country [7] 998 0
Australia
Date submitted for ethics approval [7] 998 0
Approval date [7] 998 0
Ethics approval number [7] 998 0
Ethics committee name [8] 999 0
Royal Brisbane
Ethics committee address [8] 999 0
Ethics committee country [8] 999 0
Australia
Date submitted for ethics approval [8] 999 0
Approval date [8] 999 0
Ethics approval number [8] 999 0
Ethics committee name [9] 1000 0
Royal Melbourne
Ethics committee address [9] 1000 0
Ethics committee country [9] 1000 0
Australia
Date submitted for ethics approval [9] 1000 0
Approval date [9] 1000 0
Ethics approval number [9] 1000 0
Ethics committee name [10] 1001 0
Royal North Shore
Ethics committee address [10] 1001 0
Ethics committee country [10] 1001 0
Australia
Date submitted for ethics approval [10] 1001 0
Approval date [10] 1001 0
Ethics approval number [10] 1001 0

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

Contacts
Principal investigator
Name 35822 0
Address 35822 0
Country 35822 0
Phone 35822 0
Fax 35822 0
Email 35822 0
Contact person for public queries
Name 9300 0
Dr Chris Arthur
Address 9300 0
Haematology Department
Royal North Shore Hospital
St. Leonards NSW 2065
Country 9300 0
Australia
Phone 9300 0
+61 2 99267601
Fax 9300 0
+61 2 99061635
Email 9300 0
carthur@nsccahs.health.nsw.gov.au
Contact person for scientific queries
Name 228 0
Assoc Prof Tim Hughes
Address 228 0
Division of Haematology
Institute of Medical and Veterinary Science
Frome Road
Adelaide SA 5000
Country 228 0
Australia
Phone 228 0
+61 8 82223330
Fax 228 0
+61 8 82223139
Email 228 0
timothy.hughes@imvs.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo In January 2002, the ALLG commenced a pilot study ... [More Details]

Documents added automatically
No additional documents have been identified.