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New hope for stem cell transplant patients with severe immune complication

NCT ID NCT06824103

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a drug called ruxolitinib in Chinese patients aged 12 and older who have chronic graft-versus-host disease (cGvHD) that did not improve with steroids. cGvHD is a condition where donor immune cells attack the patient's body after a stem cell transplant. The goal is to see if ruxolitinib can help control the disease without needing additional treatments. About 50 participants will take the drug and be monitored for response and safety.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

May 2031

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

12 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.

Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female Chinese participants aged 12 or older at the time of informed consent * Able to swallow tablets.- Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible. * Evident myeloid and platelet engraftment: * Absolute neutrophil count (ANC) \>1,000/mm3 AND * Platelet count ≥25,000/mm3 Note: Use of growth factor supplementation and transfusion support is allowed during the trial, however, transfusion to reach a minimum platelet count for inclusion is not allowed during screening and at baseline. * Participants with clinically diagnosed cGvHD staging of moderate to severe according to NIH Consensus Criteria (Jagasia et al 2015) prior to Cycle 1 Day 1. * Moderate cGvHD: at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1. * Severe cGvHD: at least 1 organ with a score of 3, or lung score of 2 or 3. * Participants currently receiving systemic corticosteroids for the treatment of cGvHD for a duration of \< 12 months prior to Cycle 1 Day 1, and have a confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH consensus criteria (Martin et al 2015) irrespective of the concomitant use of a calcineurin inhibitor, as follows: * A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for at least 1 week (or equivalent) OR * Disease persistence without improvement despite continued treatment with prednisone at \>0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent) OR * Increase to prednisone dose to \>0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent) * Participants has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: For a full list of exclusion criteria, refer to Section 5.2. Key exclusion criteria include * Participants who have received two or more systemic treatments for cGvHD in addition to corticosteroids ± CNI for cGvHD. * Participants who have received ROCK2 inhibitors for cGvHD. * Participants that transition from active aGvHD to cGvHD without tapering off corticosteroids ± CNI and any systemic treatment Note: Participants receiving up to 30 mg by mouth once a day of hydrocortisone (i.e., physiologic replacement dose) of corticosteroids are allowed. * Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks prior to Cycle 1 Day 1. * Failed prior alloSCT within the past 6 months from Cycle 1 Day 1. * Participants with relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed. * SR-cGvHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible. Other protocol-defined inclusion/exclusion may apply.

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease graft versus host disease

As listed by the trial registrant

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

Chronic graft VS host disease Corticosteroid-refractory chronic graft VS. host disease Graft VS host disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    RECRUITING

    Nanning, Guangxi, 530021, China

  • Novartis Investigative Site

    RECRUITING

    Guiyang, Guizhou, 550004, China

  • Novartis Investigative Site

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Novartis Investigative Site

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    RECRUITING

    Xuzhou, Jiangsu, 221003, China

  • Novartis Investigative Site

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    RECRUITING

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    RECRUITING

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100070, China

  • Novartis Investigative Site

    RECRUITING

    Changsha, 410000, China

  • Novartis Investigative Site

    RECRUITING

    Chongqing, 400016, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200025, China

  • Novartis Investigative Site

    RECRUITING

    Wujiang Nongchang, 065201, China

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