Ruxolitinib and Steroid As First Line Therapy for Acute GVHD | NCT03701698

Studies
Ruxolitinib and Steroid As First Line Therapy for Acute GVHD

NCT03701698

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Terminated

Last Update Posted

Oct 1, 2024Actual

Enrollment

1Actual

Phase

Phase 2

Conditions

Acute GVHD

Interventions

Ruxolitinib Oral Tablet
Methylprednisolone

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Participants recruitment failure

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Sep 20, 2024Actual

Completion Date

Sep 20, 2024Actual

First Submitted Date

Oct 8, 2018

First Submission Date that Met QC Criteria

Oct 8, 2018

First Posted Date

Oct 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2024

Last Update Posted Date

Oct 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xianmin Song, MD, Director, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Treatment:

Once patients are diagnosed with grade II~IV acute GVHD, the combination therapy should be initiated as soon as possible.

Methylprednisolone: 2mg/kg/d, iv or iv gtt, in two or three divided doses. Taper steroid every one or two weeks according to patient's response.
Ruxolitinib 5~10mg bid po for at least 28 days. If patient's ANC<0.5×10e9/L or PLT< 20×10e9/L, cease ruxolitinib until recovery of ANC higher than 0.5×10e9/L or PLT higher than 20×10e9/L.

Indication for stopping Ruxolitinib treatment:

No response after ruxolitinib treatment for 28 days.
Develop life-threatening complication.
ANC<0.5×10e9/L or PLT< 20×10e9/L.

Indication for second line acute GVHD treatment:

deterioration of acute GVHD in 3 days
no response after 7 days
no complete remission after 2 weeks.

Suggestions of second line therapy:

Basiliximab 20mg, d1, d4, d8.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib Oral Tablet	Drug	Ruxolitinib Oral Tablet （Jakafi）, 5~10mg bid po for at least 28 days.	combination therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
time to response	days from beginning to the first day of maximum response	28 days after treatment
reactivation rate of cytomegalovirus	reactivation rate of cytomegalovirus infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

exclusion criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xianmin Song, M.D.	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai General Hospital		Shanghai	Shanghai Municipality	200080	China

Intervention Browse Module

MeSH Terms

ID	Term
C540383	ruxolitinib
D008775	Methylprednisolone
D013256	Steroids

Ancestor Terms

ID	Term
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes

Browse Leaves

Not provided

Browse Branches

Not provided