NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Long-Term Evaluation and Follow Up Care of Patients Treated with Allogeneic Stem Cell Transplants

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 7 Years
Max Age: 80 Years

Referral Letter Required


Population Exclusion(s)



Peripheral Blood Stem Cells;
Graft Versus Leukemia/Myeloma;
Graft Versus Host Disease;
Whole Body Irradiation;
Leukemic Relapse;
Natural History

Recruitment Keyword(s)



Graft vs Host Disease;
Graft Rejection

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Heart, Lung, and Blood Institute

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of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.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:

1) 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.

2) Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine small sections of body organs and tissues.

3) Computerized tomography (CT) uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs.

4) 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:

1) Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.

2) 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.

3) 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.

--Back to Top--



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


-With a standard of care allogeneic stem cell transplant on an NHLBI protocol


-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.


None, all patients meeting the inclusion criteria will be eligible

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Richard W. Childs, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 3-5330
(301) 451-7128

Kristen Gunn E. Wood, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 44350
10 Center Drive
Bethesda, Maryland 20892
(301) 827-2977

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


--Back to Top--