Graft-versus-leukemiaNCT00106925
Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
An observational study of Graft-versus-leukemia and Graft vs Host Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Graft-versus-leukemia, Graft vs Host Disease, Graft Rejection
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2005to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None, all patients meeting the inclusion criteria will be eligible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants
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.
Read more
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.
Read the detailed description
While patients surviving more than three years from SCT have a high probability of being cured of their underlying disease, they are still at risk from several categories of complications which could remain lifelong risks including late recurrence (or continued persistence) of original disease, late effects from transplant related GVHD, immune dysfunction, or consequences from the chemotherapy and/or radiation given during transplant conditioning.
Since these complications are iatrogenic, the long term follow-up of SCT patients is the ethical responsibility of the transplant team. In addition, collecting data on late occurring complications allows for prospective evaluation of the long term consequences of surviving a particular transplant treatment approach (i.e. total body irradiation versus chemotherapy conditioning, T cell depleted versus T cell replete transplants).
This protocol is designed to allow for long term evaluation, data collection, and when needed, standard medical care of patients (and when appropriate their stem cell donor) who have received allogeneic stem cell transplantation in NHLBI protocols. This may include patients with bone marrow failure states, cytopenias, hemoglobinopathies, metastatic solid tumors, or hematologic malignancies.
No investigational treatments will be administered on this protocol. Participation will not constitute a promise of long-term medical care at the NIH, nor will it provide for the evaluation and treatment of any non-transplant related medical problems. This protocol will provide access to NIH hematologists experienced in the care of post transplant patients who can help transplant patients and their local physician manage post transplant complications. In return, data collected from subjects and their donors (when applicable) will provide NIH researchers valuable information and/or laboratory samples for the purposes of better understanding the long term consequences of stem cell transplantation and identifying areas in need of future research.
- Keywords
- Peripheral Blood Stem Cells, Graft Versus Leukemia/Myeloma, Graft Versus Host Disease, Whole Body Irradiation, Leukemic Relapse, Natural History
- Medical subject headings
- Graft vs Host Disease, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | allogeneic stem cell transplant recipients | |
| 2 | Donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ongoing
Secondary outcomes (2)
Monitor the late effects of treatment and provide or recommend appropriate management
To collect long-term follow-up data and laboratory research samples on SCT recipients to determine outcomes for particular transplant treatment approaches.
Measured: ongoing
Describe natural history of the primary disease process. Provide fellowship training in Hematology and Oncology.
Patients will be evaluated at 4, 5 and 7 years post-transplant, then every 5 years after that to monitor the natural history of their disease, to evaluate the long term effects of transplantation, and to provide for or recommend appropriate clinical management
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2005 (estimated)
- Study start22 Apr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-versus-leukemiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard W Childs, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106925
- Sponsor's protocol ID
- 050130
- Other IDs
- 05-H-0130
- Status last verified
- 6 Aug 2026
- First submitted
- 31 Mar 2005
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21421838