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Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )

ConditionsGVHD,AcuteStem Cell Transplant Complications
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorDaihong Liu

About this trial

The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for grade II acute GVHD (graft-versus-host disease )

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with hematological diseases.

Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.

New onset of grade II acute GVHD or intermediate or high risk aGVHD (based on modified GVHD Glucksberg criteria) within 100 days post-transplantation.

Disqualifiers

Recipients of second allogeneic stem cell transplant.

Acute GVHD induced by donor lymphocyte infusion, interferon.

Received first line aGVHD treatment before enrollment.

Overlap GVHD syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ruxolitinib

    Drug

    Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 0.5mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.

  • Corticosteroids

    Drug

    Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 1 week, then taper according to the clinical response.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Ruxolitinib ArmExperimental treatment 2 interventions
Group B: Comparator armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate (ORR) at Day 28

Defined as the proportion of participants demonstrating a complete response (CR), or partial response (PR).

Time frame
Day 28 after treatment

Secondary outcomes

1

Six-month duration of response

Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. Six-month duration of response will be assessed when all participants who are still on study complete the Day 180 visit.

Time frame
Six-month after treatment
2

Duration of response

Defined as the time from first response until GVHD progression or death, when all participants who are still on study complete the Day 90 visit.

Time frame
Day 90 after treatment
3

Nonrelapse mortality (NRM)

NRM was defined as death from any cause without relapse. Cumulative incidence of NRM was analyzed in a competing risk framework using Gray's method.

Time frame
1 year after treatment
4

Cumulative incidence of relapse (CIR)

Defined as the proportion of participants whose underlying malignancy relapsed.Relapse was defined as hematologic recurrence of malignancies after transplantation. Cumulative incidence of relapse was analyzed in a competing risk framework using Gray's method.

Time frame
1 year after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daihong Liu

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov
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