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Tests treatment safety and results for Graft vs. Host Disease
Official title Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
ClinicalTrials.gov ID: NCT06824103
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for graft vs. host disease.
Also referred to as INC424.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 100
You may be able to join if
- 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...
- Evident myeloid and platelet engraftment:
- Absolute neutrophil count (ANC) \>1,000/mm3 AND
You likely can't join if
- 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...
- Participants who were treated with prior JAK inhibitors for aGvHD; except when the participant achieved complete or partial response and has been off...
- Failed prior alloSCT within the past 6 months from Cycle 1 Day 1.
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Changsha, China
- Chongqing, China
- Shanghai, China
- Wujiang Nongchang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Shijiazhuang, Hebei, China; Zhengzhou, Henan, China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.