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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02386800




Registration number
NCT02386800
Ethics application status
Date submitted
6/03/2015
Date registered
12/03/2015
Date last updated
27/11/2024

Titles & IDs
Public title
CINC424A2X01B Rollover Protocol
Scientific title
Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies
Secondary ID [1] 0 0
2014-003527-22
Secondary ID [2] 0 0
CINC424A2X01B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Myelofibrosis 0 0
Polycythemia Vera 0 0
Graft Versus Host Disease 0 0
Acute Myeloid Leukemia 0 0
Thalassemia 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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

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

Experimental: Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination - All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.


Treatment: Drugs: ruxolitinib
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study

Treatment: Drugs: panobinostat
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of AEs and SAEs
Timepoint [1] 0 0
12 years
Secondary outcome [1] 0 0
Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.
Timepoint [1] 0 0
12 years
Secondary outcome [2] 0 0
Incidence and severity of AEs and SAEs by treatment group
Timepoint [2] 0 0
12 years

Eligibility
Key inclusion criteria
Key Inclusion criteria:

1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat

Key
Minimum age
1 Month
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.
2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
3. Pregnant or nursing (lactating) women.
4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.

Other protocol-defined Inclusion / Exclusion criteria may apply.

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 4
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
5/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/09/2027
Actual
Sample size
Target
Accrual to date
Final
279
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - Wooloongabba
Recruitment hospital [4] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [5] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [6] 0 0
Novartis Investigative Site - Clayton
Recruitment hospital [7] 0 0
Novartis Investigative Site - Franston
Recruitment hospital [8] 0 0
Novartis Investigative Site - Perth
Recruitment hospital [9] 0 0
Novartis Investigative Site - St Leonards
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4102 - Wooloongabba
Recruitment postcode(s) [4] 0 0
5041 - Bedford Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3199 - Franston
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment postcode(s) [9] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
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Belgium
State/province [3] 0 0
Leuven
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Belgium
State/province [4] 0 0
Liege
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Bulgaria
State/province [5] 0 0
Pleven
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Bulgaria
State/province [6] 0 0
Plovdiv
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sofia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Chile
State/province [9] 0 0
RM
Country [10] 0 0
Chile
State/province [10] 0 0
Valparaiso
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
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China
State/province [12] 0 0
Zhejiang
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China
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Beijing
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France
State/province [14] 0 0
Paris 10
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Germany
State/province [15] 0 0
Aachen
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Germany
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Dresden
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Germany
State/province [17] 0 0
Hamburg
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Germany
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Jena
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Ulm
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Greece
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Athens
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Greece
State/province [23] 0 0
Patras
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
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Hungary
State/province [25] 0 0
Debrecen
Country [26] 0 0
Hungary
State/province [26] 0 0
Kaposvar
Country [27] 0 0
Hungary
State/province [27] 0 0
Kecskemet
Country [28] 0 0
Hungary
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Szeged
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Hungary
State/province [29] 0 0
Szombathely
Country [30] 0 0
India
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Maharashtra
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Israel
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Afula
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Israel
State/province [32] 0 0
Jerusalem
Country [33] 0 0
Italy
State/province [33] 0 0
AN
Country [34] 0 0
Italy
State/province [34] 0 0
BA
Country [35] 0 0
Italy
State/province [35] 0 0
BO
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Italy
State/province [36] 0 0
BS
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Italy
State/province [37] 0 0
FG
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Italy
State/province [38] 0 0
FI
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Italy
State/province [39] 0 0
MI
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Italy
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PA
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Italy
State/province [41] 0 0
PV
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Italy
State/province [42] 0 0
RC
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Italy
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RM
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Italy
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TO
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Italy
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VA
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Italy
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Napoli
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Kanagawa
Country [51] 0 0
Japan
State/province [51] 0 0
Osaka
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Japan
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Tokyo
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Korea, Republic of
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Seocho Gu
Country [54] 0 0
Korea, Republic of
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Seoul
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Lebanon
State/province [55] 0 0
Beirut
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Mexico
State/province [56] 0 0
Nuevo Leon
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Poland
State/province [57] 0 0
Slaskie
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Poland
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Wroclaw
Country [59] 0 0
Portugal
State/province [59] 0 0
Lisboa
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Petrozavodsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Saint Petersburg
Country [63] 0 0
South Africa
State/province [63] 0 0
Gauteng
Country [64] 0 0
South Africa
State/province [64] 0 0
Western
Country [65] 0 0
South Africa
State/province [65] 0 0
Pretoria
Country [66] 0 0
Spain
State/province [66] 0 0
Castilla Y Leon
Country [67] 0 0
Spain
State/province [67] 0 0
Catalunya
Country [68] 0 0
Spain
State/province [68] 0 0
Navarra
Country [69] 0 0
Sweden
State/province [69] 0 0
Huddinge
Country [70] 0 0
Sweden
State/province [70] 0 0
Lulea
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Sweden
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Lund
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Sweden
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Uddevalla
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Thailand
State/province [73] 0 0
Bangkok
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Turkey
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Ankara
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Turkey
State/province [75] 0 0
Istanbul
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Turkey
State/province [76] 0 0
Izmir
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Turkey
State/province [77] 0 0
Talas Kayseri

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
Trial website
https://clinicaltrials.gov/study/NCT02386800
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
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
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
+41613241111
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02386800