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

The Impact of Pediatric Marrow Transplantation on Late Pulmonary Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00009711
Enrollment
280
Registered
2003-01-27
Start date
1996-03-31
Completion date
2005-08-31
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

long-term effects secondary to cancer therapy in children, pulmonary complications

Brief 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.

Detailed 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.

Interventions

PROCEDUREmanagement of therapy complications

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fred Hutchinson Cancer Center
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026