Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00109707




Registration number
NCT00109707
Ethics application status
Date submitted
2/05/2005
Date registered
3/05/2005
Date last updated
29/06/2021

Titles & IDs
Public title
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies
Scientific title
A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
Secondary ID [1] 0 0
CAMN107A2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myelogenous Leukemia 0 0
Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) 0 0
Hypereosinophilic Syndrome 0 0
Systemic Mastocytosis 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
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Skin 0 0 0 0
Other skin conditions
Blood 0 0 0 0
Other blood disorders
Blood 0 0 0 0
Haematological diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: CML-CP With Prior Imatinib Only - Imatinib-resistant / intolerant PH+ CML-CP patients

Experimental: CML-AP With Prior Imatinib Onl - Imatinib-resistant / intolerant PH+ CML-AP patients

Experimental: CML-CP - Imatinib-resistant / intolerant PH+ CML-CP patients
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Major Cytogenetic Response (MCyR)
Timepoint [1] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Primary outcome [2] 0 0
Number of Participants Confirmed Overall Hematological Response (Phase II)
Timepoint [2] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Secondary outcome [1] 0 0
Number of Participants With Overall Major Cytogenetic Responses (Phase II)
Timepoint [1] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Secondary outcome [2] 0 0
Number of Participants With Complete Hematologic Response (Phase II)
Timepoint [2] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Secondary outcome [3] 0 0
Participants With (MMR) Major Molecular Response (Phase II)
Timepoint [3] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Secondary outcome [4] 0 0
Time to Progression (TTP) (Phase II)
Timepoint [4] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Secondary outcome [5] 0 0
Overall Survival (OS) (Phase II)
Timepoint [5] 0 0
Up to End of the Treatment (Approximately 7.5 years)
Secondary outcome [6] 0 0
Number of Participants With Adverse Events and Serious Adverse Events to Evaluate Long Term Safety
Timepoint [6] 0 0
From First Participant First Visit to Last Participant Last Visit (Approximately 7.5 years)

Eligibility
Key inclusion criteria
Main inclusion criteria include:

* Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: *developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- *patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- *have developed an intolerance to imatinib
* Relapsed or refractory Ph+ ALL
* Hypereosinophilic syndrome/chronic eosinophilic leukemia.
* Systemic mastocytosis who have a clinical indication for treatment.
* Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required
* CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible
* Written informed consent prior to any study procedures being performed
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Impaired cardiac function
* Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease)
* Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs )
* Women who are pregnant or breastfeeding
* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
* Patients unwilling to comply with the protocol.
* Known diagnosis of human immunodeficiency virus (HIV) infection

Other protocol-defined inclusion/exclusion criteria may apply

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
Parallel
Other design features
Phase
Phase 1
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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
507
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Wien
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
State/province [20] 0 0
Haine-saint-Paul
Country [21] 0 0
Belgium
State/province [21] 0 0
Leuven
Country [22] 0 0
Belgium
State/province [22] 0 0
Yvoir
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Denmark
State/province [26] 0 0
Vejle
Country [27] 0 0
Finland
State/province [27] 0 0
HUS Helsinki
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux Cedex
Country [29] 0 0
France
State/province [29] 0 0
Créteil
Country [30] 0 0
France
State/province [30] 0 0
Dijon
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Limoges cedex
Country [33] 0 0
France
State/province [33] 0 0
Lyon
Country [34] 0 0
France
State/province [34] 0 0
Marseille
Country [35] 0 0
France
State/province [35] 0 0
Poitiers
Country [36] 0 0
France
State/province [36] 0 0
Rennes
Country [37] 0 0
France
State/province [37] 0 0
Vandoeuvre les Nancy
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Duesseldorf
Country [40] 0 0
Germany
State/province [40] 0 0
Frankfurt/M
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Leipzig
Country [43] 0 0
Germany
State/province [43] 0 0
Mainz
Country [44] 0 0
Germany
State/province [44] 0 0
Mannheim
Country [45] 0 0
Germany
State/province [45] 0 0
Muenchen
Country [46] 0 0
Hong Kong
State/province [46] 0 0
Pokfulam
Country [47] 0 0
Italy
State/province [47] 0 0
BG
Country [48] 0 0
Italy
State/province [48] 0 0
BO
Country [49] 0 0
Italy
State/province [49] 0 0
GE
Country [50] 0 0
Italy
State/province [50] 0 0
MB
Country [51] 0 0
Italy
State/province [51] 0 0
MI
Country [52] 0 0
Italy
State/province [52] 0 0
PE
Country [53] 0 0
Italy
State/province [53] 0 0
PV
Country [54] 0 0
Italy
State/province [54] 0 0
RC
Country [55] 0 0
Italy
State/province [55] 0 0
RM
Country [56] 0 0
Italy
State/province [56] 0 0
TO
Country [57] 0 0
Italy
State/province [57] 0 0
Napoli
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Jeollanam-do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Korea
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Taegu
Country [61] 0 0
Netherlands
State/province [61] 0 0
Amsterdam
Country [62] 0 0
Netherlands
State/province [62] 0 0
Rotterdam
Country [63] 0 0
New Zealand
State/province [63] 0 0
Auckland
Country [64] 0 0
Norway
State/province [64] 0 0
Oslo
Country [65] 0 0
Poland
State/province [65] 0 0
Katowice
Country [66] 0 0
Poland
State/province [66] 0 0
Lodz
Country [67] 0 0
Poland
State/province [67] 0 0
Warszawa
Country [68] 0 0
Poland
State/province [68] 0 0
Wroclaw
Country [69] 0 0
Singapore
State/province [69] 0 0
Singapore
Country [70] 0 0
Spain
State/province [70] 0 0
Catalunya
Country [71] 0 0
Sweden
State/province [71] 0 0
Göteborg
Country [72] 0 0
Sweden
State/province [72] 0 0
Linköping
Country [73] 0 0
Sweden
State/province [73] 0 0
Lund
Country [74] 0 0
Sweden
State/province [74] 0 0
Uppsala
Country [75] 0 0
Switzerland
State/province [75] 0 0
Basel
Country [76] 0 0
Switzerland
State/province [76] 0 0
Genève
Country [77] 0 0
Taiwan
State/province [77] 0 0
Niaosong Township
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Birmingham
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Cambridge
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Glasgow - Scotland
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Leeds
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Liverpool
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticlas
Address 0 0
Novartis Pharmaceuticals
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00109707