Study of Lung Function in Children Who Have Undergone Bone Marrow Transplantation

Pulmonary Complications Clinical Trial

Official title:

The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009711
• Other study ID #: 1097.00
• Secondary ID: FHCRC-1097.00NCI
• Status: Completed
• Phase: N/A
• First received: February 2, 2001
• Last updated: April 29, 2013
• Start date: March 1996
• Est. completion date: August 2005

Study information

• Verified date: April 2013
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

RATIONALE: Assessing the long-term effects of bone marrow transplant on lung function in patients may improve the ability to plan treatment.

PURPOSE: This clinical trial studies lung function in pediatric patients who have undergone bone marrow transplant.

Description:

OBJECTIVES:

• Determine the delayed effects of bone marrow transplantation preparative regimens on pulmonary function in children surviving at least 5 years after transplantation for hematologic malignancy.

• Determine the relationship between pulmonary function and growth rates in these patients.

• Determine the effect of growth hormone treatment on pulmonary function in these patients.

• Determine the relationship between pulmonary function and age at time of transplantation in these patients.

• Determine the incidence and severity of restrictive pulmonary disease, and whether these factors vary with increasing time after transplantation in these patients.

OUTLINE: Patients undergo respiratory history, signs and symptoms assessment, pulmonary function tests (PFT) including spirometry, lung volumes, and diffusion, oxygen saturation by pulse oximetry, and height measurement.

Patients are assessed at 5-10 years, 10-15 years, and over 15 years after bone marrow transplantation. Patients with abnormal PFTs are assessed at more frequent intervals as clinically indicated.

PROJECTED ACCRUAL: Approximately 280 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 2005
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

DISEASE CHARACTERISTICS:

• Patients who have undergone bone marrow transplantation for hematologic malignancy at least 5 years ago

• Disease-free survivors at least 6 years of age AND

• Under 18 years of age at time of transplantation

• Received prior allogeneic, unrelated donor, syngeneic, or autologous bone marrow transplantation

• Able to perform pulmonary function tests

PATIENT CHARACTERISTICS:

Age:

• See Disease Characteristics

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• Any prior preparative regimen allowed

Study Design

N/A

Related Conditions & MeSH terms

• Long-term Effects Secondary to Cancer Therapy in Children
• Pulmonary Complications

Intervention

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,