TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

Recruiting

• Conditions: Diffuse Alveolar Hemorrhage; Hematopoietic Stem Cell Transplant (HSCT); Thrombotic Microangiopathies; Interstitial Pneumonitis; Bronchiolitis Obliterans

• Registration Number: NCT04098445
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.

This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Study Start: 2021-09-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-09
• Study Completion: 2036-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.

Exclusion Criteria

• Subjects over 24 years of age.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Lung Injury after HSCT	24 months after HSCT	Participants will be assessed for lung injury at 24 months after HSCT

Trial Locations

Locations (8)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Baylor College of Medicine/Texas Children'S Hospital; 🇺🇸 Houston, Texas, United States

Seattle Children'S Hospital; 🇺🇸 Seattle, Washington, United States

Dana-Farber Cancer Institute/Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Fred Hutchinson Cancer Center; 🇺🇸 Seattle, Washington, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States