This study allows the evaluation of subjects in order to determine their ability to safely
participate in other active research studies.
After subjects complete the screening process, they will be offered the opportunity to
participate in an active research study, or if no appropriate studies are available
information and recommendations will be provided for other treatment options.
This protocol is designed for screening of subjects before a decision can be made as to their
eligibility for one of the active Hematology Branch research protocols. Its purpose is to
allow detailed investigation into the hematologic or oncologic problems of these subjects,
and the status of other organ systems that would determine their ability to safely tolerate
specific aspects of active research protocols. It allows investigation as to whether a donor
is HLA matched, fit to receive G-CSF, and fit to undergo apheresis and therefore eligible to
participate as a donor on a bone marrow transplant protocol. It also allows the investigation
as to whether subjects are eligible for participation as normal volunteer based on protocol
eligibility criteria that requires generally good health status by history or physical exam
findings, or laboratory assessments. After completion of this screening process, the subject
will either be offered a chance to participate in an active research protocol, or if no
appropriate protocol is identified, subjects with hematologic or oncologic disease will have
recommendations for other treatment options relayed to the primary or referring physician.
Primary objective is to determine subject eligibility for participation on Hematology Branch
tissue procurement or investigative therapy protocols.
Primary endpoint is the results of clinical, imaging and laboratory assessments.
- INCLUSION CRITERIA:
Subjects will be entered on this protocol at the time of their first visit to the NIH
Clinical Center outpatient clinic or inpatient service if:
The subject carries the diagnosis of a disorder for which the Hematology Branch has an
active research protocol, and based on information received from an outside physician,
he/she appears to meet at least preliminary eligibility criteria for that protocol.
The subject is a donor for a subject for which the Hematology Branch has an active stem
cell transplant protocol and based on information received from an outside physician,
he/she appears to meet preliminary eligibility as a donor.
The subject is a normal volunteer for which the Hematology Branch has an active study
recruiting healthy normal volunteers and he/she appears to meet preliminary eligibility as
a normal volunteer.
Age greater than or equal to 2.
Weight greater than 12 kg. (Healthy Volunteer greater than or equal to 8)
The subject or the subject's guardian is capable of informed consent, and willing to sign
the consent form after initial counseling by clinical staff. Separate consent forms for all
interventional or surgical procedures will be obtained after explanation of the specific
All subjects not fulfilling the inclusion criteria will be considered ineligible.
Cynthia E Dunbar, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Sophia Grasmeder, R.N.
Phone: (301) 827-0367