GVHD-budesonide trial

JRCT ID: jRCTs021210039

Registered date:29/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intestinal acute GVHD
• Date of first enrollment: 29/09/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Stage 1 of intestinal acute GVHD: Budesonide 9 mg once daily after breakfast + prednisolone 1 mg/kg daily in 2 divided doses. Stage 2-4 of intestinal acute GVHD: Budesonide 9 mg once daily after breakfast + prednisolone 2 mg/kg daily in 2 divided doses.

Outcome(s)

• Primary Outcome: Overall response rate after 28 days of treatment
• Secondary Outcome: adverse events, reduction rate of systemic steroids, incidence and exacerbation rates of acute GVHD in non-intestinal tracts

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

(1) Intestinal acute GVHD
(2) Untreated
(3) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 to 2
(4) Written informed consent

Exclude criteria

(1) Post-treatment for GVHD
(2) Skin GVHD stage 3 or higher, liver GVHD stage 1 or higher.
(3) Active infection
(4) Intestinal disease due to other causes (e.g. CMV enteritis, thrombotic microangiopathy)

Related Information

• Primary Sponsor: Yamashita Takaya
• Secondary Sponsor: Takahashi Naoto
• Source(s) of Monetary Support: Akita University Hospital