Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

The aim of this study is to demonstrate that in subjects with moderate to severe chronic graft-versus-host disease in the third line and beyond, the use of rosuvastatin compared to the protocol chosen by the researchers can significantly improve the objective response rate of subjects at week 24.

Eligibility criteria

Qualifiers

Age: 18 to 70 years old; Karnofsky (KPS) ≥ 60 points; Expected survival period exceeding 6 months;

Previously received allogeneic hematopoietic stem cell transplantation;

According to NIH standards, the clinical diagnosis is moderate to severe cGVHD;

Previously received systematic treatment for cGVHD with 2-5 lines;

Disqualifiers

Has experienced or currently suffers from other malignant tumors within the past 3 years;

Known or suspected active aGVHD;

Individuals with interstitial pneumonia, non infectious pneumonia, uncontrolled active infections, or infections requiring systematic treatment within the first 7 days of randomization, except for those deemed suitable for inclusion by the researchers;

The occurrence and progression of other underlying diseases include post transplant lymphoid tissue proliferative diseases and recurrence of primary malignant hematological diseases;

Trial design

Treatments tested in this trial

  • Rovadicitinib
  • Imatinib
  • Methotrexate
  • Mycophenolate mofetil
  • Rituximab

Treatment groups

182 Participants
are divided into 2 treatment groups