Ruxolitinib for Newly Diagnosed Bronchiolitis Obliterans Syndrome

Status Recruiting

Clinical Trial Summary

Lung is one of the target organs in chronic graft versus host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Bronchiolitis obliterans syndrome (BOS) after allo-HSCT was a clinical syndrome characterized by persistent airflow restriction which is the result of lung cGVHD. BOS is one of the main causes of late mortality after allo-HSCT, severely restricting the daily activities and respiratory function of patients. It limits the quality of life and increased the non-relapse mortality (NRM) after allo-HSCT. Currently, the first-line treatment for BOS is FAM ( oral fluticasone, azithromycin and montelukast). However, more than 50% of patients develop as steroids resistant (SR)-BOS, and SR-BOS has a poor prognosis and irreversible impaired lung function. Ruxolitinib is an effective drug in the treatment of SR-cGVHD. This is a phase Ⅱ prospective clinical study to explore the efficacy and safety of ruxolitinib as a first-line treatment for newly diagnosed BOS after allo-HSCT.

Clinical Trial Description

The incidence of chronic graft versus host disease (cGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) was 30%-70%, Which extremely limited the quality of life and the survival of patients after allo-HSCT. Lung is one of the target organs in cGVHD after allo-HSCT. Bronchiolitis obliterans syndrome (BOS) after allo-HSCT was a clinical syndrome characterized by persistent airflow restriction which is the result of lung cGVHD. BOS is one of the main causes of late mortality after allo-HSCT, severely restricting the daily activities and respiratory function of patients. It limits the quality of life and increased the non-relapse mortality (NRM) after allo-HSCT. Currently, the first-line treatment for BOS is FAM ( oral fluticasone, azithromycin and montelukast). However, more than 50% of patients develop as steroids resistant (SR)-BOS, and SR-BOS has a poor prognosis and irreversible impaired lung function. Ruxolitinib is an effective drug in the treatment of SR-cGVHD. This is a phase Ⅱ prospective clinical study to explore the efficacy and safety of ruxolitinib as a first-line treatment for newly diagnosed BOS after allo-HSCT. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05413356
Study type	Interventional
Source	First Affiliated Hospital of Zhejiang University
Contact	Yi Luo, M.D.
Phone	+86057187233801
Email	luoyijr@163.com
Status	Recruiting
Phase	Phase 2
Start date	June 1, 2022
Completion date	January 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Recruiting	`NCT04889937` - Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Not yet recruiting	`NCT05820126` - Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial	Phase 2
Active, not recruiting	`NCT04509765` - A Phase II Single-arm Study of Total Body Irradiation With Linac Based VMAT and IGRT	N/A
Not yet recruiting	`NCT06350994` - Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Not yet recruiting	`NCT05443854` - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)	Phase 3
Withdrawn	`NCT04282174` - CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies	Phase 2
Withdrawn	`NCT03986086` - MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation	Phase 1/Phase 2
Completed	`NCT02512666` - Non Invasive Optical Imaging of WBC Count	N/A
Not yet recruiting	`NCT02193399` - Physiotherapy in Hematopoietic Stem Cell Transplantation	N/A
Withdrawn	`NCT02207764` - Reiki as a Complementary Therapy: A Pilot Study	N/A
Terminated	`NCT01846429` - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain	Phase 1
Terminated	`NCT01215981` - Influenza Vaccine Post Allogeneic Transplant	N/A
Completed	`NCT00333190` - CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation	N/A
Withdrawn	`NCT04392128` - Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)	Phase 2
Recruiting	`NCT06102213` - Study To Evaluate The Safety And Efficacy of PBCLN-010 In Combination With PBCLN-014 in Participants Receiving Allogeneic Hematopoietic Cell Transplantation	Phase 2
Active, not recruiting	`NCT04552288` - Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies	Phase 2
Completed	`NCT03654404` - A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients	N/A
Recruiting	`NCT05384288` - Response to Influenza Vaccination in Pediatric Oncology Patients
Recruiting	`NCT05084027` - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT	Phase 2