Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925 | Recruiting

• 2 other identifiers: 05013005-H-0130
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.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

Conditions

Graft-versus-leukemia; Graft vs Host Disease; Graft Rejection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assure consistency of care over time for transplant patients such that outcome data can be meaningfully accrued.

  monitor late effects of treatment and provide or recommend appropriate management

  Ongoing

Secondary Outcomes (2)

• Monitor the late effects of treatment and provide or recommend appropriate management

  ongoing

• Describe natural history of the primary disease process. Provide fellowship training in Hematology and Oncology.

  ongoing

Study Arms (2)

1

allogeneic stem cell transplant recipients

2

Donors

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and donors (when applicable) will be co accrued to this protocol once they have survived a minimum of three years from date of transplant.

You may qualify if:

• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• Le RQ, Melenhorst JJ, Battiwalla M, Hill B, Memon S, Savani BN, Shenoy A, Hensel NF, Koklanaris EK, Keyvanfar K, Hakim FT, Douek DC, Barrett AJ. Evolution of the donor T-cell repertoire in recipients in the second decade after allogeneic stem cell transplantation. Blood. 2011 May 12;117(19):5250-6. doi: 10.1182/blood-2011-01-329706. Epub 2011 Mar 18.

  PMID: 21421838 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Graft vs Host Disease; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Richard W Childs, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bretagne C Cowling, R.N.

CONTACT

(301) 827-3479; bretagne.cowling@nih.gov

Richard W Childs, M.D.

CONTACT

(301) 768-9433; childsr@nhlbi.nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2005
• First Posted: April 1, 2005
• Study Start: April 22, 2005
• Last Updated: June 4, 2026

Record last verified: 2026-06-02

Locations

US (1)