SHR0302 and Steroid as First Line Therapy for Chronic GVHD

Chronic GVHD Clinical Trial

Official title:

SHR0302 and Prednisone as First Line Therapy for Chronic Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04146207
• Other study ID #: SHSYXY-cGVHD-2019002
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 2, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Huiying Qiu, M.D.
• Phone: 86-21-37798987
• Email: qiuhy5[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of SHR0302 in combination with Prednisone as first line therapy in patients with moderate to severe chronic graft-versus-host disease (GVHD).

Description:

Treatment: Once patients are diagnosed with chronic GVHD, the combination therapy should be initiated as soon as possible. 1. Prednisone: 1mg/kg/d po. Taper steroid every two weeks according to patient's response. 2. SHR0302 QD po. for at least 28 days. Indication for stopping SHR0302 treatment: 1. No response after SHR0302 treatment for 12 weeks. 2. Develop life-threatening complication. 3. ANC<0.5×10e9/L or PLT< 30×10e9/L.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• = 18 years old and = 70 years old, male or female;

• Patients receiving allogeneic peripheral blood stem cell transplantation for hematological diseases;

• The primary hematological malignancies are completely relieved and are expected to be stable for at least 3 months;

• Chronic GVHD that was first attacked after transplantation and at least 100 days after transplantation, reached a moderate or severe level by NIH classification;

• There was no previous systemic treatment (including in vitro illumination [ECP]);

• The patient may be receiving other immunosuppressive agents to prevent or treat acute GVHD, but if the subject receives prednisone to prevent or treat acute GVHD, it must be <0.5 mg/kg/d or equivalent dose of other glucocorticoids;

• The chronic GVHD that has started hormone therapy does not exceed 72 hours;

• Karnofsky score > 60 points;

• Patients must be able to understand and are willing to participate in the study and sign an informed consent form.

Exclusion Criteria:

• Can not tolerate prednisone dose 1mg / kg / d or equivalent dose of other glucocorticoids for the treatment of cGVHD;

• Receive any systemic treatment of cGVHD, except for corticosteroids that treat cGVHD within 72 hours prior to the signing of informed consent;

• Patients with GVHD overlap syndrome (NIH criteria);

• Treatment of acute GVHD has received other Jak inhibitors such as ruxolitinib;

• Pregnant or lactating women;

• The patient is judged by the investigator to have complications that may cause other risks;

• The patient is receiving other study medications;

• Patient blood routine: ANC <1.0 × 109 / L or PLT < 50 × 109 / L;

• Non-GVHD-related liver damage: the aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio is more than 3 times normal or the direct bilirubin normal value is more than 3 times;

• Renal dysfunction: endogenous creatinine clearance (Ccr) < 50mL/min or normal serum creatinine 1.5 times or more, regardless of hemodialysis treatment;

• Uncontrolled infections: hemodynamic instability associated with infection, or new signs or signs of infection, or new infections in imaging, persistent fever without symptoms or signs and cannot be ruled out Infected person

• People living with HIV;

• Active hepatitis B (HBV), active hepatitis C (HCV) requires antiviral therapy; patients with HBV activation risk refer to patients with hepatitis B surface antigen-positive or core antibody-positive patients who are not treated with anti-HBV;

• The patient's primary malignant disease recurs and the graft is rejected;

• Those who are allergic to known JAK inhibitors.

Related Conditions & MeSH terms

• Chronic GVHD

Intervention

Drug:
• SHR0302
SHR0302 po QD
• Prednisone
Prednisone 1mg/kg/d po

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai
China	Xianmin Song	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of SHR0302 and prednisone	The severity of adverse events is determined according to the CTCAE V5.0 criteria.	After the first dose of SHR0302 or prednisone until 30 days after the last dose of SHR0302 or prednisone.
Secondary	Overall response rate (ORR) at week 4	Response rate at week 4 (the proportion of responders [CR or PR]) as defined by the NIH Consensus Development Project (2014)	Within 4 weeks
Secondary	Overall response rate (ORR) at week 24	Response rate at week 24 (the proportion of responders [CR or PR]) as defined by the NIH Consensus Development Project (2014)	Within 24 weeks