SHR0302 and Steroid As First Line Therapy for Chronic GVHD

NCT04146207 | Completed Early Phase 1 DMC

• 1 other identifier: SHSYXY-cGVHD-2019002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Chronic GVHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall response rate (ORR) at week 4

  Within 4 weeks

• Overall response rate (ORR) at week 24

  Within 24 weeks

Study Arms (1)

combination therapy

EXPERIMENTAL

Experimental: combination therapy There is only 1 arm. Combination therapy arm includes SHR0302 and Prednisone Prednisone 1mg/kg/d po，At the same time give SHR0302 QDpo；

Drug: SHR0302; Drug: Prednisone

Interventions

SHR0302 DRUG

SHR0302 po QD

combination therapy

Prednisone DRUG

Prednisone 1mg/kg/d po

combination therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (2)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Xianmin Song

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

ivarmacitinib; Prednisone

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xianmin Song, M.D.

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 31, 2019
• Study Start: April 2, 2020
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)