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Completed

NCT Number: NCT05663827

Ruxolitinib as add-on Therapy in Steroid-refractory Graft-vs-host Disease

Steroid-refractory graft-vs-host disease (SR-GVHD) is a major cause of mortality after allogeneic hematopoietic stem cell transplantation (HSCT). We sought to evaluate the effect and safety of ruxolitinib (RUX) add-on in the treatment of patients with SR-GVHD.

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Key information

About this study

Nowadays, second-line treatment for SR-GVHD differs between centers and depends on the physician's experience. The agents commonly used as second and further lines of therapy include anti-thymocyte globulin, mycophenolate mofetil, calcineurin inhibitor, or extracorporeal photopheresis. However, the response varied. This study highlighted that corticosteroid (CS) is not a panacea for treating GVHD, and some patients with remission still experience further relapse. Additionally, the identification of multiple infections adds complexity.

Hope was supposed to come in 2019 after the Food and Drug Administration (FDA) approved RUX for the therapy of SR-GVHD in adult and pediatric patients > 12 years. RUX add-on should be withheld as the risks outweigh the benefits, especially for patients who developed scleroderma and bronchiolitis obliterans. RUX can be added on as needed for the treatment of GVHD, especially in patients receiving DLI as relapse therapy with the conversion from mixed chimerism to complete chimerism. Despite some studies showing the efficacy of RUX across affected organs, some other data bring the opposite results. Thus we conducted this study to reinforce the efficacy of RUX as an add-on therapy for SR-GVHD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with hematologic disorder

Exclusion criteria

  • Those who are not applicable of receiving Ruxolitinib as immunodeficiency-modulation therapy
  • Those who are actively encountering acute infectious illness

Treatment and study plan

Ruxolitinib

Drug

A dosage of 5mg once daily will be applied as initiation. After one week use, dose escalation or de-escalation would depend on clinical response.

Other names: Jakavi

Primary outcomes

  1. GI symptoms secondary to GVHD

    Time frame: 3 years

    Diarrhea event exceeds a frequency of 5 times a day

  2. Skin symptoms secondary to GVHD

    Time frame: 3 years

    Skin rash extends more than 25% of body surface area

Secondary outcomes

  1. Overall survival

    Time frame: 3 years

    From diagnosis of SR-GVHD to mortality due to any cause

Sponsors and collaborators

Lead sponsor

Yi-Lun Wang

Other

Registry information

Official study title

Ruxolitinib Add-on in Steroid-refractory Graft-vs-host Disease After Allogeneic Stem Cell Transplantation: a Single Institutional Experience

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Dec 23, 2022
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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