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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03193281




Registration number
NCT03193281
Ethics application status
Date submitted
15/06/2017
Date registered
20/06/2017

Titles & IDs
Public title
KISS Study: Kinase Inhibition With Sprycel Start up
Scientific title
KISS Study: A Phase II Study of Dasatinib Followed by Imatinib in Newly Diagnosed, Previously Untreated Patients With Chronic Phase CML
Secondary ID [1] 0 0
CTNZ-2012-08
Universal Trial Number (UTN)
Trial acronym
KISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Treatment: Drugs - Imatinib

Other: Dasatinib - All patients will begin the study on dasatinib treatment (Sprycel® 100mg once daily oral administration). Those who reach MR3.0 at 12 months (end of Study Stage 1) and achieve a confirmed result at 13 months, will switch to imatinib treatment (Imatinib-AFT 400mg once daily oral administration) for the next 24 months (Study Stage 2).

Patients who do not achieve a confirmed MR3.0 result at 13 months will not be eligible to switch to imatinib treatment and will remain on dasatinib treatment, as per Study Stage 1.

Patients will be assessed on a 3-monthly basis throughout the study. Those who discontinue dasatinib treatment during the study for reasons other than the planned treatment switch to imatinib at 13 months, will also be followed up every 3 months.


Treatment: Drugs: Dasatinib
In order to test the study hypothesis patients need to stay on dasatinib (Sprycel) treatment for the first 12 months of the study (Stage 1).

Patients who do not reach MR3.0 at 12 months will remain on dasatinib treatment.

Treatment: Drugs: Imatinib
Patients who reach MR3.0 at 12 months (and the result is confirmed at 13 months) will switch to imatinib (Imatinib-AFT) treatment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To estimate the proportion of patients who remain in MR3.0 for the duration of 2 years following a change of therapy from dasatinib to imatinib at 13 months.
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
To estimate progression free survival (PFS), failure free survival (FFS) and overall survival (OS) for patients that switch to imatinib at 13 months.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
To estimate the proportion of patients who regain MR3.0 on dasatinib or another TKI therapy after having a confirmed loss of MR3.0 on imatinib, for patients that switch to imatinib at 13 months.
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
To estimate time to MR3.0, MR4.5 and MR5.0 for patients that switch to imatinib at 13 months.
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
To describe adverse event profiles on Stage 1 and Stage 2 of the study and overall for patients that switch to imatinib at 13 months.
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
To describe the quality of life on Stage 1 and Stage 2 of the study and overall for those that switch to imatinib at 13 months.
Timepoint [5] 0 0
3 years

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

1. Male or female patients = 18 years of age.
2. ECOG performance status score of 0-2.
3. Patients must have all of the following:

1. Be enrolled within 3 months of initial diagnosis of CML-CP (date of initial diagnosis is the date of first cytogenetic analysis).
2. Cytogenetic or molecular confirmation of Ph+ or variants of (9;22) translocations.

patients may have secondary chromosomal abnormalities in addition to the Ph+.
3. Documented chronic phase CML as defined by:

* < 15% blasts in peripheral blood and bone marrow.
* < 30% blasts plus promyelocytes in peripheral blood and bone marrow.
* < 20% basophils in peripheral blood.
* = 100 x 109/L platelets (unless considered related to hydroxyurea).
* no evidence of extramedullary leukaemic involvement, with the exception of hepatosplenomegaly.
4. BCR-ABL1 transcript that can be monitored by Q-PCR.
5. Baseline full blood count (within 14 days of enrolment) remains consistent with chronic phase CML criteria.
4. Voluntary written informed consent.

EXCLUSION CRITERIA:

1. Any prior treatment for CML with other than hydroxyurea.
2. Patients with the following laboratory values:

1. serum bilirubin > 2.0 x the institutional upper limit of the normal range (ULN).
2. ALT > 2.0 x the institutional upper limit of the normal range (ULN).
3. creatinine > 2.0 x the institutional upper limit of the normal range (ULN).
4. International normalised ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants.
3. Patients with uncontrolled medical disease such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders or infection.
4. Patients with:

1. Grade 3/4 cardiac problems as defined by the New York Heart Association Criteria.
2. Uncontrolled hypertension.
3. Grade 3/4 respiratory dysfunction.
4. Past or current history of pleural effusions or pulmonary arterial hypertension.
5. Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required.
6. Patients who have undergone major surgery within 4 weeks of study Day 0, or who have not recovered from prior major surgery.
7. Patients who are:

1. pregnant.
2. breast feeding.
3. of childbearing potential without a negative pregnancy test on/prior to Day 0.
4. male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
8. Patients with another uncontrolled malignancy with the exception of basal cell skin carcinoma or cervical carcinoma in situ.
9. Patients with positivity for hepatitis B antigen and / or hepatitis B core antibody (unless receiving prophylactic therapy with lamivudine or more potent agent)
10. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
New Zealand
State/province [5] 0 0
New Plymouth
Country [6] 0 0
New Zealand
State/province [6] 0 0
Palmerston North
Country [7] 0 0
New Zealand
State/province [7] 0 0
Takapuna
Country [8] 0 0
New Zealand
State/province [8] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Leukaemia & Blood Cancer New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Peter Browett, MBChB
Address 0 0
University of Auckland, New Zealand
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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 not provided in https://clinicaltrials.gov/study/NCT03193281