A Single-arm Multi-center Study of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Novartis Investigative Site
RECRUITING
Changsha
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Hangzhou
Novartis Investigative Site
RECRUITING
Hefei
Novartis Investigative Site
RECRUITING
Shijiazhuang
Novartis Investigative Site
RECRUITING
Wenzhou
Novartis Investigative Site
RECRUITING
Zhejiang
Novartis Investigative Site
RECRUITING
Zhengzhou
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2032-01-11
Participants
Target number of participants: 50
Treatments
Experimental: Ruxolitinib
Chinese participants (adult and pediatric) who will receive ruxolitinib daily.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov