Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 2 - 80 |
| Updated: | 3/31/2019 |
| Start Date: | March 30, 2005 |
| Contact: | Kristen E Wood, R.N. |
| Email: | kristen.gunn@nih.gov |
| Phone: | (301) 827-2977 |
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.
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amount of marrow is withdrawn.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.
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.
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 investigators 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.
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 investigators 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.
- 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
-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 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 laboratory 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.
No additional stem cells will be harvested for research purposes.
EXCLUSION CRITERIA-DONOR (ANY OF THE FOLLOWING):
- Pregnant or actively breastfeeding
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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