CINC424A2X01B Rollover Protocol

Acute Myeloid Leukemia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02386800
• Other study ID #: CINC424A2X01B
• Secondary ID: 2014-003527-22
• Status: Recruiting
• Phase: Phase 4
• Start date: March 5, 2015
• Est. completion date: September 16, 2027

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 356
• Est. completion date: September 16, 2027
• Est. primary completion date: September 16, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis
• Thalassemia

Intervention

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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Darlinghurst	New South Wales
Australia	Novartis Investigative Site	Franston	Victoria
Australia	Novartis Investigative Site	Herston	Queensland
Australia	Novartis Investigative Site	Perth	Western Australia
Australia	Novartis Investigative Site	St Leonards	New South Wales
Australia	Novartis Investigative Site	Wooloongabba	Queensland
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Chile	Novartis Investigative Site	Santiago	RM
Chile	Novartis Investigative Site	Santiago
Chile	Novartis Investigative Site	Vina del Mar	Valparaiso
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Hangzhou	Zhejiang
Denmark	Novartis Investigative Site	Copenhagen
France	Novartis Investigative Site	Paris 10
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Ulm
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Patras
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kaposvar
Hungary	Novartis Investigative Site	Kecskemet
Hungary	Novartis Investigative Site	Szeged
Hungary	Novartis Investigative Site	Szombathely
India	Novartis Investigative Site	Pune	Maharashtra
Israel	Novartis Investigative Site	Afula
Israel	Novartis Investigative Site	Jerusalem
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Orbassano	TO
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Reggio Calabria	RC
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	San Giovanni Rotondo	FG
Italy	Novartis Investigative Site	Varese	VA
Japan	Novartis Investigative Site	Bunkyo ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka city	Fukuoka
Japan	Novartis Investigative Site	Isehara	Kanagawa
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Sapporo city	Hokkaido
Japan	Novartis Investigative Site	Suita	Osaka
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Lebanon	Novartis Investigative Site	Beirut
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Poland	Novartis Investigative Site	Gliwice	Slaskie
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	Saint Petersburg
Slovakia	Novartis Investigative Site	Bratislava
South Africa	Novartis Investigative Site	Cape Town	Western Province
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Pretoria
South Africa	Novartis Investigative Site	Soweto	Gauteng
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Pamplona	Navarra
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Sweden	Novartis Investigative Site	Huddinge
Sweden	Novartis Investigative Site	Lulea
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Uddevalla
Thailand	Novartis Investigative Site	Bangkok
Turkey	Novartis Investigative Site	Ankara	Sihhiye
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Talas / Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Chile,  China,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Mexico,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of AEs and SAEs	The incidence of treatment-emergent AEs and SAEs (new or worsening from baseline) will be summarized by system organ class and/or preferred term, severity (based on CTCAE grades).	12 years
Secondary	Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.	The analysis of clinical benefit will be descriptive only and cannot be compared to efficacy results of other studies. In addition, as clinical benefit was only added in protocol amendment 1, it may not be available for all participants.	12 years
Secondary	Incidence and severity of AEs and SAEs by treatment group	AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)	12 years