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New drug access for Hard-to-Treat blood cancer patients

NCT ID NCT05269771

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
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 Results may not be published yet.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) This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program offers ruxolitinib (Jakavi) to people aged 12 and older with polycythemia vera, a blood cancer that causes too many red blood cells. It is for patients whose disease has not responded to or who cannot take standard treatments like hydroxyurea. Participants take daily tablets at home under their doctor's guidance.

What this could mean

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

Active substance
ruxolitinib (also known as Jakavi)
What this could lead to
If successful, this program could provide a treatment option for polycythemia vera patients who have not responded to or cannot tolerate standard therapies.
What could go wrong
This is an access program, not a formal trial, so it does not test whether ruxolitinib works better than other options. Results may not apply to all patients, and side effects are possible.

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.

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

12 to 99 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.

Inclusion Criteria: Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria: 1. Male or female aged 12 or over 2. Confirmed diagnosis of PV based on World Health Organization (WHO) criteria 3. Patients must have a treatment history for PV that meets the definition of resistance or intolerance to hydroxyurea (HU) or other cytoreductive therapy 4. Patients with a peripheral blood blast count of 0% at screening 5. Patients must have recovered or stabilized sufficiently from adverse drug reactions associated with prior treatments before beginning treatment with ruxolitinib 6. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 Written patient informed consent must be obtained prior to start of treatment. Exclusion Criteria: Patients eligible for this Treatment Plan must not meet any of the following criteria: 1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib. 2. Presence of an active uncontrolled infection including significant bacterial, fungal, viral (including CMV, EBV, HHV-6, HBV, HCV, BK or HIV) or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Patients with inactive chronic infection (without viral replication) can be enrolled. 3. History of progressive multifocal leuko-encephalopathy (PML). 4. Presence of severely impaired renal function defined by serum creatinine \> 2 mg/dL (\>176.8 μmol/L), or have estimated creatinine clearance \< 30 ml/min measured or calculated by Cockroft Gault equation. 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are * women whose sexual orientation precludes intercourse with a male partner. * women whose partners have been sterilized by vasectomy or other means. * using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable throughout the period of treatment and 30 days after treatment discontinuation. Any female aged 8 years and above is to be treated as a woman of child-bearing potential. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL \[for US only: and estradiol \< 20 pg/mL\] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential. 6. Pregnancy 7. Not able to understand and to comply with treatment instructions and requirements

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera

As listed by the trial registrant

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

Polycythemia vera

Contacts and locations

Locations

  • Novartis Investigative Site

    Orange, New South Wales, 2800, Australia

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Calgary, Alberta, T2N 2T9, Canada

  • Novartis Investigative Site

    Tehran, 11367, Iran

  • Novartis Investigative Site

    Kfar Saba, Israel, 44281, Israel

  • Novartis Investigative Site

    Kfar Saba, 44281, Israel

  • Novartis Investigative Site

    Rehovot, 7610001, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Tel Giborim Holon, 58100, Israel

  • Novartis Investigative Site

    Groningen, 9700RB, Netherlands

  • Novartis Investigative Site

    Gdansk, 80-214, Poland

  • Novartis Investigative Site

    Katowice, 40-027, Poland

  • Novartis Investigative Site

    Krakow, 31-501, Poland

  • Novartis Investigative Site

    Warsaw, 00-791, Poland

  • Novartis Investigative Site

    Warsaw, 04-141, Poland

  • Novartis Investigative Site

    Wałbrzych, 58-309, Poland

  • Novartis Investigative Site

    Wroclaw, 50-367, Poland

  • Novartis Investigative Site

    Hereford, HR1 2ER, United Kingdom

  • Novartis Investigative Site

    Kent, CT9 4AN, United Kingdom

  • Novartis Investigative Site

    London, NW3 2PF, United Kingdom

  • Novartis Investigative Site

    London, SE5 8AD, United Kingdom

  • Novartis Investigative Site

    London, WC1E 6HX, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LJ, United Kingdom

  • Novartis Investigative Site

    Poole, BH15 2JB, United Kingdom

  • Novartis Investigative Site

    Salisbury, SP2 8BJ, United Kingdom

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