NCT04239989

Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant

A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVE: I. To assess the safety of itacitinib in patients with bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT). SECONDARY OBJECTIVES: I. To assess treatment failure at 3 months and 6 months. II. To assess change in symptom-based lung score at 3 months and 6 months. III. To assess change in the St. George Respiratory Questionnaire and Study Short Form 36 at 3 months and 6 months. IV. To assess change in the Lee chronic graft versus host disease (GVHD) symptom scale at 3 months and 6 months post-treatment. V. To assess change in 6-minute walk test at 3 months and 6 months. VI. To assess failure-free survival at 6 months. VII. To assess non-relapse mortality at 6 months. VIII. To assess overall survival at 6 months. OUTLINE: Patents receive itacitinib orally (PO) once daily (QD) for up to 1 year in the absence of disease progression or unacceptable toxicity.

Conditions

• Bronchiolitis Obliterans

Interventions

Type	Name	Description
DRUG	Itacitinib	Given PO
DRUG	Itacitinib Adipate	Given PO

Timeline

• Start date: 2021-10-08
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2020-01-27
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study