Protocol Number: 05-H-0130

Title:

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

Number:

05-H-0130

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of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.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

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.

Sponsoring Institute:

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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 the NHLBI standard of care protocol

Or

-As a special exemption to the above protocols

Age greater than or equal to 10 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

INCLUSION CRITERIA-DONOR

If appropriate clinical management of the recipient or ongoing labortory research would indicate the need for additional stem cell collection or peripheral blood collection, a donor may also be accrued to this protocol providing they meet the following criteria:

-HLA 5/6 or 6/6 matched family donor

-Weight greater than or equal to 18 kg

-Age greater than or equal to 2 or less than or equal to 80 years old

-Age greater than or equal to 18 years of age (if participating only as a donor of peripheral blood cells for laboratory research studies.)

-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-DONOR (ANY OF THE FOLLOWING)

-Pregnant or lactating

-Donor unfit to receive filgrastim and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia)

-HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the risk-benefit ratio is considered acceptable by the patient and investigator.

Special Instructions:

Currently Not Provided

Keywords:

Late Effects

Peripheral Blood Stem Cell Transplant

PBSCT

Allogeneic Stem Cell Transplant

Peripheral Blood Stem Cells

Graft-Versus Leukemia/Myeloma

Graft-Versus-Host Disease

Whole Body Irradiation

Leukemic Relapse

Graft Rejection

Recruitment Keyword(s):

Allogeneic Stem Cell Transplantation Recipient

Condition(s):

Stem Cell Transplantation

Transplantation, Homologous

Allogenic Stem Cell Transplant Recipient

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Heart, Lung and Blood Institute

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Maury S, Prolonged immune deficiency following allogeneic stem cell transplantation: risk factors and complications in adult patients. Br J Haematol. 2001 Dec;115(3):630-41.

Storek J, Infectious morbidity in long-term survivors of allogeneic marrow transplantation is associated with low CD4 T cell counts. Am J Hematol. 1997 Feb;54(2):131-8.

Maraninchi D, Impact of T-cell depletion on outcome of allogeneic bone-marrow transplantation for standard-riskleukaemias. Lancet. 1987 Jul 25;2(8552):175-8.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/17/2008