Taking people in United StatesNo phase

Follow-up care of people who received donor stem cell transplants

Monitors people after donor stem cell transplant for relapse and later effects.

Key facts

Who runs it: National Heart, Lung, and Blood Institute (NHLBI)
Where: Bethesda, United StatesSee the site
Trial code: NCT00106925
Registry title: Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
Status: Recruiting
People taking part: 1,000 people, planned
Started: 22 Apr 2005
Type of study: Observational, 2 groups
Record updated: 5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who had a donor stem cell transplant at least 3 years ago, mostly at the NIH under an NHLBI protocol, for long-term check-ups.

Age: 7 to 80 years old.
Sex: All sexes can join.
Earlier treatment: Must have had an allogeneic (donor) stem cell transplant, and be alive 3 years or more after the first transplant. Usually the transplant was on an NHLBI protocol. A transplant done outside the NIH may be accepted for a special condition of interest to the research team.

Main reasons for not taking part

Survival of less than 3 years after the first stem cell transplant
No allogeneic stem cell transplant on an NHLBI protocol (outside transplants only in selected cases)
Adults who cannot understand the study and give consent
Children without written consent from a parent or guardian

The registry criteria, word for word

Show all 2 criteriaShow less

Who cannot take part

None, all patients meeting the inclusion criteria will be eligible

Other 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 7 and 80 years old?

Where in United States

National Institutes of Health Clinical CenterBethesda, United StatesContact: Bretagne C Cowling, R.N.Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.