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Recruiting NCT06300320

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

Phase II Interventional Chronic Graft Versus Host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TQ05105 tablets.
Who it may be relevant to
Registry conditions: Chronic Graft Versus Host Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).

Overview

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease

Interventions

  • Drug TQ05105 tablets
    Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.

Primary outcome measures

  • Objective response rate (ORR) at 24 weeks [Time frame: Up to 24 weeks]
Secondary outcome measures (8)
  • Best objective response rate (BOR) [Time frame: Up to 48 weeks]
  • Duration of response (DOR) [Time frame: Up to 48 weeks]
  • Failure-free survival (FFS) [Time frame: Up to 48 weeks]
  • Incidence rate of malignancy relapse or recurrence [Time frame: Up to 48 weeks]
  • Non relapse mortality [Time frame: At least 48 weeks]
  • Overall Survival (OS) [Time frame: At least 48 weeks]
  • Adverse event rate [Time frame: Up to 48 weeks]
  • Severity of adverse events (AEs) [Time frame: Up to 48 weeks]

Eligibility criteria

Inclusion criteria

  • Voluntary and signed informed consent, good compliance;
  • Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.
  • Received allogeneic hematopoietic stem cell transplantation;
  • Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)
  • Received systemic therapies for cGVHD;
  • Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;
  • Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ；platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function;
  • Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study

Exclusion criteria

  • Currently present or occured other malignancies within 3 years prior to first administration;
  • Known or suspected active acute graft versus host disease (aGVHD);
  • Presence of infection requiring treatment within 7 days prior to randomization;
  • Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;
  • Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;
  • Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;
  • Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
  • Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;
  • Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;
  • Those who are allergic to the study drug or its components;
  • Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;
  • Subjects judged by the investigator to be unsuitable for enrollment;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 12 centers
  • Anhui Provincial Hospital — Hefei
  • The 940th hospital of joint logistics support force of Chinese people's liberation army — Lanzhou
  • Guangzhou First People's Hospital — Guangzhou
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • The Second Hospital of Hebei Medical University — Shijiazhuang
  • Xiangyang Central Hospital — Xiangyang
  • Tai'an Central Hospital — Taian
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
  • … and 4 more centers

Identifiers

NCT: NCT06300320 · TQ05105-II-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗