This study will evaluate the reliability of a new test called Real-Time Polymerase chain
reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course
of CMV disease in patients who have recently had a bone marrow transplant. The test's
effectiveness will be compared with that of the "pp65 antigenemia assay" now routinely used
for this purpose.
CMV is a common virus that is transmitted from person to person by close personal contact.
In most healthy people, CVM can remain in the body indefinitely without causing any harm.
But, in people with weakened immune systems-including those who have just undergone bone
marrow transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs
are available to treat this infection, however. Optimum treatment depends on early and
Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH
Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase
1, patients will have blood drawn for both RT PCR and antigenemia testing once before the
bone marrow transplantation and then weekly for the first 100 days after the transplant.
During Phase 2-which begins immediately after the end of phase 1 and continues for one year
after the transplant-blood samples for both tests will be drawn up to once a week. The
samples for both tests will be collected at the same time and will be taken through a
catheter (a thin flexible tube inserted into a vein) that has already been placed for the
transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above
what is needed for antigenemia testing, amounting to a maximum of about one-half pint extra
over the course of the 1-year study.
It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV
infection and predicting disease development, thus enabling doctors to plan early and
Currently, it is the standard of care to use the pp65 antigenemia assay to guide
anti-cytomegalovirus therapy in hematopoietic stem cell transplant patients. Nevertheless,
over the past two years at our institution, only approximately 10% of antigenemia-positive
patients went on to develop overt CMV disease and only 22% of patients with documented
clinical CMV disease had a positive antigenemia test in the two weeks prior to diagnosis
(data on file).
Recently, a test called CMV Real-Time PCR has been applied to the diagnosis of CMV
infection. Preliminary data suggests that this test may be of value in detecting active CMV
replication. Thus, it may be able to predict CMV disease and help guide antiviral therapy.
We propose a prospective observational study comparing CMV Real-Time PCR test and pp65
antigenemia. This will be done by taking an extra blood sample (approximately 5 mL) for the
CMV Real-Time PCR test from hematopoietic stem cell transplant patients whenever a sample
for the pp65 antigenemia test is drawn. No separate venipunctures are anticipated. These
samples will be drawn on an approximately weekly basis during the first 100 days
post-transplant, as is currently done for the pp65 antigenemia test alone. Additionally, at
any time blood is drawn for the pp65 antigenemia test after 100 days, we will also take
blood for the CMV Real-Time PCR test, up to one year post-transplant. The results of the
CMV Real-Time PCR test will not be used to guide therapy. Overt CMV disease will be
identified via real-time chart review and patient interviews by one of the investigators in
the study. The primary goal of the study is to evaluate the ability of the CMV Real-Time
PCR test to accurately detect active CMV viral proliferation and predict ultimate overt CMV
disease as compared to the currently-used pp65 antigenemia test.
Male or female patients that are 10 years of age or older up to 80 years of age are
Patients must be enrolled in a protocol at the NIH Clinical Center that will result in the
patient receiving an allogeneic stem cell transplant (A-HSCT).
Patients who have not yet received a pre-transplant chemotherapy and radiation therapy
conditioning regimen are eligible.
Patients must not have a negative IgG serologic test for CMV and whose hematopoietic stem
cell donor also has a negative IgG serologic test as reported by the Bone Marrow
Patients must not have documentation of prior cytomegalovirus antigenemia or disease prior
to starting the conditioning regimen.