Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-01 @ 11:48 PM
Study NCT ID:
NCT06824103
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed Description:
This is a single arm, multi-center, open label study which will enroll approximately 50 participants and investigate the efficacy and safety of ruxolitinib administered in adult and adolescent (≥12 years old) Chinese participants with SR-cGvHD.
The total duration on study for an individual participant will be up to 164 weeks (approximately 3 years).
The study consists of following periods, with each cycle comprised of 4 weeks (28 days):
* Screening Period (Day -28 to Day -1)
* Treatment period (Day 1 to Cycle 39/EOT)
* Safety follow-up (Last dose +30 days)
* Long-term survival follow-up period (EOT to 156 weeks on study).
The total duration on study for an individual participant will be up to 164 weeks (approximately 3 years).
The study consists of following periods, with each cycle comprised of 4 weeks (28 days):
* Screening Period (Day -28 to Day -1)
* Treatment period (Day 1 to Cycle 39/EOT)
* Safety follow-up (Last dose +30 days)
* Long-term survival follow-up period (EOT to 156 weeks on study).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: