Recruiting

Lung Diseases

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT06093867

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Eligibility Criteria

Sex: All

Age: 5 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

Stem cell transplants (called hematopoietic stem cell transplantation, or HSCT) are used to treat various diseases. But when the cells for this procedure are donated by someone other than the person who receives the HSCT ( allogeneic HSCT ), the recipient has an increased risk of lung inflammation and scarring. This happens when their immune cells attack healthy lung cells. In this natural history study, researchers will look for the best ways to detect developing lung inflammations earlier after an HSCT.

Objective:

To see if certain tests can detect early signs of lung inflammation in people after HSCT.

Eligibility:

People aged 5 to 70 years who will have HSCT as part of another NIH study.

Design:

Participants will undergo these tests prior to their HSCT. These tests will then be repeated regularly for 2 years:

Ultra-low dose computed tomography (CT) scans. Participants will lie on a table that slides through a machine; the machine uses X-rays to get pictures of the inside of the body. This type of scan uses less radiation than normal CT scans.

Bronchoscopy with lavage: Participants will be sedated. A flexible tube will be inserted through the mouth and into the airways. Salt water will be squirted into the lung, then sucked out to collect cells and fluids from the lung. Another tube with a camera may be inserted into the airways to take pictures.

Blood tests. Blood will be drawn every 2 to 4 weeks.

Pulmonary function tests. Participants will breathe into a machine to test their lung function. They will see how far they can walk in 6 minutes.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Study ID

NCT06093867

Start date

Apr 8, 2024

Status verified date

Jul 10, 2026

Completion date

Oct 1, 2030

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with all study procedures and availability for the duration of the study.
2. Male or female, aged 5 - 70 years of age
3. Are to be treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorders at the NIH Clinical Center.
4. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1\. Pregnancy or lactation

a. HSCT is not available to pregnant women or lactating women in the intramural program. For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

allogeneic HSCT

Up to 30 men or women, 18 - 70 years of age, who are being treated with allogeneic HSCT for a hematologic malignancy, blood, or immune system disorder at the NIH Clinical CenterUp to 10 children 5 - 17 years of age who are being treated with allogeneic HSCT for a hematologic malignancies, blood, or immune system disorder at the NIH Clinical CenterNIH Clinical Center

Primary outcome measure

  • To use preemptive assessments with sequential chest imaging and BAL measures to provide earlier identification of lung injury due to infection or alloreactive lung syndromes associated with HSCT. [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Gloria Y Pastor, C.R.N.P.

(301) 402-3484pastorg@cc.nih.gov

Anthony F Suffredini, M.D.

(301) 496-9320asuffredini@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

Gloria Pastor

(301) 402-3484gloria.pastor@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Jul 14, 2026

Last verified

Jul 10, 2026

Keywords

  • allogeneic hematopoietic stem cell transplantation (HSCT)
  • early detection of inflammatory injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-07-14.