CINC424A2X01B Rollover Protocol

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

ClinicalTrials.gov Identifier: NCT02386800

Novartis Reference Number: CINC424A2X01B

Last Update: Sep 28, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Primary Myelofibrosis
Polycythemia Vera
Graft Versus Host Disease
Acute Myeloid Leukemia
Thalassemia
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Mar 05, 2015
Completion date 
Sep 16, 2027
Gender 
All
Age(s)
1 Years and older (Child, Adult, Older Adult)

Interventions

Drug
ruxolitinib
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
Drug
panobinostat
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study

Eligibility Criteria

Key Inclusion criteria:

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.
Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
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 Exclusion criteria:

Patient has been permanently discontinued from study treatment in the parent study due to any reason.
Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
Pregnant or nursing (lactating) women.
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 Locations

Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
China
Novartis Investigative Site
Recruiting
Beijing, 100730
Beijing
China
India
Novartis Investigative Site
Recruiting
Pune, 411004
Maharashtra
India
Italy
Novartis Investigative Site
Recruiting
Brescia, 25123
BS
Italy
Novartis Investigative Site
Recruiting
Firenze, 50134
FI
Italy
Novartis Investigative Site
Recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Recruiting
Palermo, 90146
PA
Italy
Novartis Investigative Site
Recruiting
Pavia, 27100
PV
Italy
Novartis Investigative Site
Recruiting
Reggio Calabria, 89124
RC
Italy
Novartis Investigative Site
Recruiting
Roma, 00165
RM
Italy
Novartis Investigative Site
Recruiting
Varese, 21100
VA
Italy
Japan
Novartis Investigative Site
Recruiting
Nagoya, 466 8560
Aichi
Japan
Novartis Investigative Site
Recruiting
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
Recruiting
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
Recruiting
Isehara, 259-1193
Kanagawa
Japan
Novartis Investigative Site
Recruiting
Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
Recruiting
Bunkyo ku, 113-8677
Tokyo
Japan
Novartis Investigative Site
Recruiting
Osaka, 545-8586
-
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Poland
Novartis Investigative Site
Recruiting
Gliwice, 44-101
Slaskie
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 50 367
-
Poland
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 125167
-
Russian Federation
Novartis Investigative Site
Recruiting
Sain Petersburg, 197022
-
Russian Federation
South Africa
Novartis Investigative Site
Recruiting
Cape Town, 7800
Western Province
South Africa
Novartis Investigative Site
Recruiting
Pretoria, 0044
-
South Africa
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
Sihhiye
Turkey
Novartis Investigative Site
Recruiting
Istanbul, 34093
-
Turkey
Novartis Investigative Site
Recruiting
Izmir, 35040
-
Turkey
Novartis Investigative Site
Recruiting
Talas / Kayseri, 38039
-
Turkey

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]