A study evaluating safety and efficacy of Itacitinib or Placebo in combination with corticosteroids for the treatment of first-line acute graft versus-host disease

Phase 1

• Conditions: Male or female, 18 years of age or older who have received an allogeneic hematopoietic stem cell transplant (allo-HSCT) and have developed Grade II to IV acute GVHD; MedDRA version: 20.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10066262Term: Acute graft versus host disease in skinSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10066263Term: Acute graft versus host disease in liverSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-000538-78-GB
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-24
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• Male or female, 18 years of age or older.
• Has undergone 1 allo-HSCT from any donor (related or unrelated with
any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
• Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen. Biopsies should be obtained to pathologically confirm aGVHD; in cases where a biopsy is negative, is unable to be obtained, or is clinically contraindicated, clinical suspicion of aGVHD by the treating physician is sufficient, provided that alternative diagnoses of drug effects or infection are adequately ruled out.
• Evidence of myeloid engraftment (eg, absolute neutrophil count = 0.5 × 109/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 393
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

• Has received more than 1 allo-HSCT.
• Has received more than 2 days of systemic corticosteroids for acute-GVHD.
• Presence of GVHD overlap syndrome.
• Presence of an active uncontrolled infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified