Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
National Heart, Lung, and Blood Institute (NHLBI) · NCT00106925
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 7–80 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 1000
- US sites recruiting
- 1
- Study start
- April 22, 2005
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.
Patients between 10 and 80 years of age who received a donor stem cell transplant at the NIH Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.
Participants are generally seen in the clinic every 12 months for some or all of the following procedures:
- Periodic physical examinations, eye examinations, and blood and urine tests.
- Bone marrow aspiration and biopsy: A sample of bone marrow is obtained for microscopic examination. The patient is given local anesthesia or conscious sedation. An area of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.
- Tissue biopsy: A small piece of tissue or tumor is obtained for microscopic examination. Depending on the site of the biopsy, the tissue may be removed using a cookie cutter-like "punch" instrument, a needle, or a knife. The area is numbed and the tissue is removed with the appropriate tool.
- Imaging tests to visualize organs, tissues, and cellular activity in specific tissues. For these tests, the patient lies on a table that slides into the scanner. They may include the following:
- Nuclear scans use a sensitive camera to track a small amount of radioactive material (radioisotope) that is given to the patient by mouth or through a vein. The scan may show abnormal areas of tissue in the bones, liver, spleen, kidney, brain, thyroid, or spine.
- Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine small sections of body organs and tissues.
- Computerized tomography (CT) uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs.
- Positron emission tomography (PET) uses a fluid with a radioisotope attached to it to show cellular activity in specific tissues. The fluid is given through a vein and travels to the cells that are most active (like cancer cells), showing if there is an actively growing tumor.
- Pulmonary (lung) function tests: The patient breathes into a machine that measures the volume of air the person can move into and out of the lungs.
- Heart function tests may include the following:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
- Multiple gated acquisition scan (MUGA) is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
Disease relapse or progression, or transplant-related problems may be treated with standard medical, radiation, or surgical therapy, or patients may be offered experimental therapy.
Conditions: Graft-versus-leukemia; Graft vs Host Disease; Graft Rejection
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
- INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:
Patients surviving three years or more from date of first stem cell transplant who have been treated.
-With an experimental allogeneic stem cell transplant on a NHLBI HB protocol
Or
-With a standard of care allogeneic stem cell transplant on an NHLBI protocol
Or
-Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team
Age greater than or equal to 7 years old and age less than or equal to 80
For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.
EXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS:
None, all patients meeting the inclusion criteria will be eligible
Recruiting US locations
National Institutes of Health Clinical Center
Bethesda, MD 20892
Study contacts (from the official record)
- Bretagne C Cowling, R.N. · (301) 827-3479 · bretagne.cowling@nih.gov
- Richard W Childs, M.D. · (301) 768-9433 · childsr@nhlbi.nih.gov
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