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El ensayo clínico NCT06824103 para Graft vs. Host Disease, Chronic Graft vs. Host Disease, Corticosteroid-refractory Chronic Graft vs. Host Disease está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Estudio de eficacia y seguridad de ruxolitinib en participantes chinos con enfermedad de injerto contra huésped crónica resistente a los corticoesteroides Fase IV 50 Pediátrico

Reclutando
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El ensayo clínico NCT06824103 está diseñado para estudiar el tratamiento de Graft vs. Host Disease, Chronic Graft vs. Host Disease, Corticosteroid-refractory Chronic Graft vs. Host Disease. Es un estudio intervencionista de Fase IV. Su estado actual es: reclutando. El estudio se inició el 9 de septiembre de 2025, con el objetivo de reclutar a 50 participantes. Dirigido por Novartis, se espera que finalice el 11 de enero de 2032. Los datos se actualizaron por última vez en ClinicalTrials.gov el 26 de noviembre de 2025.
Resumen
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).
Descripción detallada
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...

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Título oficial

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

Condiciones médicas
Graft vs. Host DiseaseChronic Graft vs. Host DiseaseCorticosteroid-refractory Chronic Graft vs. Host Disease
Otros ID del estudio
  • CINC424D2413
Número del NCT
NCT06824103
Inicio del estudio (real)
2025-09-09
Última actualización
2025-11-26
Fecha de finalización (estimada)
2032-01-11
Inscripción (prevista)
50
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Reclutando
Palabras clave
cGvHD
GvHD
SR-cGvHD
ruxolitinib
INC424
Chinese adult
Pediatric
Corticosteroid
refractory
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalRuxolitinib
Chinese participants (adult and pediatric) who will receive ruxolitinib daily.
Ruxolitinib
Ruxolitinib is taken orally daily at 10 mg BID, given as two 5 mg tablets.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Overall Response Rate (ORR)
ORR is defined as the percentage of participants demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response, according to National Institute of Health (NIH) Consensus Criteria.
Cycle 7 Day 1; each Cycle =28 days
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Failure-free Survival (FFS)
FFS is defined as the time from the date of start of study treatment to the earliest of: i) relapse or recurrence of underlying disease or death due to underlying disease, ii) nonrelapse mortality, or iii) addition or initiation of another systemic therapy for cGvHD.
up to 3 years
Best Overall Response (BOR)
Percentage of participants who achieved overall response (CR+PR) at any time point (up Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD).
at any point up to cycle 7 day 1 (each cycle is 28 days) or the start of additional systemic therapy for cGvHD, approx. 6 months
ORR at end of cycle 3
Percentage of participants who achieved overall response (CR+PR) at Cycle 4 Day 1.
end of cycle 3; each cycle = 28 days
Duration of Response (DOR)
DOR is assessed for responders only and is defined as the time from first response until cGvHD progression, death, or the date of addition of systemic therapies for cGvHD.
from first response until cGvHD progression, death, or the date of addition of systemic therapies for cGvHD, approx.36 months
Overall Response (OS)
OS is defined as the time from the date of study treatment (ruxolitinib) initiation to the date of death due to any cause.
from the date of study treatment (ruxolitinib) initiation to the date of death due to any cause, approx. 36 months
Non-Relapse Mortality (NRM)
NRM is defined as the time from date of study treatment (ruxolitinib) initiation to date of death not preceded by underlying disease relapse/recurrence.
from date of study treatment (ruxolitinib) initiation to date of death not preceded by underlying disease relapse/recurrence, approx. 36 months
Malignancy Relapse/Recurrence (MR)
Malignancy relapse/recurrence is defined as the time from date of study treatment to hematologic malignancy relapse/recurrence.
from date of study treatment to hematologic malignancy relapse/recurrence, approx. 36 months
Reduction of daily corticosteroids dose at cycle 7 day 1
Systemic corticosteroid use is the percentage of participants with \>=50% reduction from baseline in daily corticosteroid dose, the proportion of subjects with reduction from baseline to ≤ 0.2 mg/kg/day methylprednisolone (or equivalent dose of ≤ 0.25 g/kg/day prednisone or prednisolone), and subjects successfully tapered off all systemic corticosteroids at Cycle 7 Day 1, by time intervals and overall.
Cycle 7 Day 1; each cycle = 28 days
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Niño, Adulto, Adulto mayor
Edad mínima
12 Years
Criterios de sexo
Todos

  • 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

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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Contactos centrales del estudio
Contacto: Novartis Pharmaceuticals, +41613241111, [email protected]
Contacto: Novartis Pharmaceuticals
19 Centros del estudio en 1 países

Anhui

Novartis Investigative Site, Hefei, Anhui, 230001, China
Reclutando

Guangdong

Novartis Investigative Site, Guangzhou, Guangdong, 510000, China
Reclutando
Novartis Investigative Site, Guangzhou, Guangdong, 510515, China
Reclutando

Guangxi

Novartis Investigative Site, Nanning, Guangxi, 530021, China
Reclutando

Guizhou

Novartis Investigative Site, Guiyang, Guizhou, 550004, China
Reclutando

Hebei

Novartis Investigative Site, Shijiazhuang, Hebei, 050000, China
Reclutando

Henan

Novartis Investigative Site, Zhengzhou, Henan, 450003, China
Reclutando

Hubei

Novartis Investigative Site, Wuhan, Hubei, 430030, China
Reclutando

Jiangsu

Novartis Investigative Site, Nanjing, Jiangsu, 210029, China
Reclutando

Jiangxi

Novartis Investigative Site, Nanchang, Jiangxi, 330006, China
Reclutando

Sichuan

Novartis Investigative Site, Chengdu, Sichuan, 610041, China
Reclutando

Zhejiang

Novartis Investigative Site, Hangzhou, Zhejiang, 310003, China
Reclutando
Novartis Investigative Site, Ningbo, Zhejiang, 315016, China
Reclutando
Novartis Investigative Site, Wenzhou, Zhejiang, 325000, China
Reclutando
Novartis Investigative Site, Beijing, 100034, China
Reclutando
Novartis Investigative Site, Beijing, 100070, China
Reclutando
Novartis Investigative Site, Changsha, 410000, China
Reclutando
Novartis Investigative Site, Shanghai, 200025, China
Reclutando
Novartis Investigative Site, Shanhecun, 065201, China
Reclutando