Ruxolitinib and Steroid As First Line Therapy for Acute GVHD

NCT03701698 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: SHSYXY-Ruxo-GVHD-2018001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with Grades II to IV acute graft-versus-host disease (GVHD).

Conditions

Acute GVHD

Outcome Measures

Primary Outcomes (1)

• overall response rate

  overall response rate of acute GVHD treatment, including complete response rate and partial response rate after combination therapy.

  28 days after treatment

Secondary Outcomes (3)

• time to response

  28 days after treatment

• reactivation rate of cytomegalovirus

  100 days within transplant

• 1 year incidence of chronic GVHD

  1 year within transplant

Study Arms (1)

combination therapy

EXPERIMENTAL

There is only 1 arm. Combination therapy arm includes ruxolitinib and methylprednisolone. 1. Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response. 2. Ruxolitinib oral tablet, 5\~10mg bid orally, for at least 28 days.

Drug: Ruxolitinib Oral Tablet; Drug: Methylprednisolone

Interventions

Ruxolitinib Oral Tablet DRUG

Ruxolitinib Oral Tablet （Jakafi）, 5\~10mg bid po for at least 28 days.

Also known as: Jakafi

combination therapy

Methylprednisolone DRUG

Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.

Also known as: steroid

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:

• diagnosed with hematological diseases.
• recipients of allogeneic peripheral blood stem cell transplantation.
• new onset of grade II\~IV acute graft versus host disease within 100 days post-transplantation.

You may not qualify if:

• recipients of second allogeneic stem cell transplant.
• acute GVHD induced by donor lymphocyte infusion, interferon.
• received treatment other than steroid before enrollment.
• overlap GVHD syndrome.
• pregnant or breast-feeding women.
• absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
• non-GVHD related liver dysfunction: glutamic pyruvic transaminase\>= 4 times of upper normal limit, direct bilirubin \>= 4 times of upper normal limit
• renal dysfunction: creatinine clearance \< 15 mL/min or glomerular filtration rate\< 15 mL/min
• uncontrolled infection
• human immunodeficiency virus infection
• active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
• relapse of primary malignant hematological diseases, or graft rejection.
• allergic history to Janus kinase inhibitors.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Interventions

ruxolitinib; Methylprednisolone; Steroids

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; 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: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: November 1, 2018
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)