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Drug Combo's Long-Term safety under scrutiny in blood disease patients

NCT ID NCT02386800

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study follows patients who have already been taking ruxolitinib alone or with panobinostat in earlier trials and are still benefiting. Researchers will track side effects over time to see how safe these drugs are for long-term use. About 296 participants with conditions like myelofibrosis, polycythemia vera, or graft-versus-host disease are being monitored.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ruxolitinib and panobinostat
What this could lead to
If successful, this study could confirm that these drugs are safe for long-term use in conditions like myelofibrosis and graft-versus-host disease.
What could go wrong
This is an open-label, long-term safety study, not designed to prove effectiveness. Side effects may still emerge over time, and results may not apply to new patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

279 people

The number who actually took part.

Started

Mar 2015

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera acute myeloid leukemia Bronchiolitis Obliterans Syndrome graft versus host disease primary myelofibrosis thalassemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Graft versus host disease Polycythemia vera Primary myelofibrosis Thalassemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    Herston, Queensland, 4029, Australia

  • Novartis Investigative Site

    Wooloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Bedford Park, South Australia, 5041, Australia

  • Novartis Investigative Site

    Box Hill, Victoria, 3128, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Franston, Victoria, 3199, Australia

  • Novartis Investigative Site

    Perth, Western Australia, 6000, Australia

  • Novartis Investigative Site

    St Leonards, 2065, Australia

  • Novartis Investigative Site

    Leuven, Vlaams Brabant, 3000, Belgium

  • Novartis Investigative Site

    Antwerp, 2020, Belgium

  • Novartis Investigative Site

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Plovdiv, 4002, Bulgaria

  • Novartis Investigative Site

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    Toronto, Ontario, M5G 1X8, Canada

  • Novartis Investigative Site

    Santiago, RM, 7500922, Chile

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 2540364, Chile

  • Novartis Investigative Site

    Santiago, 8420383, Chile

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Magdeburg, 39120, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Athens, 115 27, Greece

  • Novartis Investigative Site

    Pátrai, 265 04, Greece

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Budapest, 1097, Hungary

  • Novartis Investigative Site

    Kaposvár, 7400, Hungary

  • Novartis Investigative Site

    Kecskemét, 6001, Hungary

  • Novartis Investigative Site

    Szeged, H 6725, Hungary

  • Novartis Investigative Site

    Szombathely, H-9700, Hungary

  • Novartis Investigative Site

    Pune, Maharashtra, 411004, India

  • Novartis Investigative Site

    Afula, 1834111, Israel

  • Novartis Investigative Site

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    Ancona, AN, 60020, Italy

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Palermo, PA, 90146, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124, Italy

  • Novartis Investigative Site

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    Varese, VA, 21100, Italy

  • Novartis Investigative Site

    Naples, 80138, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 453-8511, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138677, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Osaka, 5458586, Japan

  • Novartis Investigative Site

    Beirut, 113-0236, Lebanon

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64718, Mexico

  • Novartis Investigative Site

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • Novartis Investigative Site

    Wroclaw, 50-367, Poland

  • Novartis Investigative Site

    Lisbon, 1099-023, Portugal

  • Novartis Investigative Site

    Lisbon, 1649-035, Portugal

  • Novartis Investigative Site

    Moscow, 125167, Russia

  • Novartis Investigative Site

    Moscow, 125284, Russia

  • Novartis Investigative Site

    Moscow, 129110, Russia

  • Novartis Investigative Site

    Petrozavodsk, 185019, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197022, Russia

  • Novartis Investigative Site

    Pretoria, Gauteng, 0181, South Africa

  • Novartis Investigative Site

    Soweto, Gauteng, 2013, South Africa

  • Novartis Investigative Site

    Cape Town, Western, 7800, South Africa

  • Novartis Investigative Site

    Pretoria, 0027, South Africa

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Salamanca, 37007, Spain

  • Novartis Investigative Site

    Huddinge, SE-14186, Sweden

  • Novartis Investigative Site

    Luleå, SE 971 80, Sweden

  • Novartis Investigative Site

    Lund, 221 85, Sweden

  • Novartis Investigative Site

    Uddevalla, 451 80, Sweden

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

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