Overview

Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV) infection caused by a stem cell transplant. PURPOSE:This clinical trial studies infection prophylaxis and management in treating cytomegalovirus infection in patients with hematologic malignancies previously treated with donor stem cell transplant.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antiviral Agents
Foscarnet
Ganciclovir
Ganciclovir triphosphate
Phosphonoacetic Acid
Valganciclovir
Criteria
Inclusion Criteria:

- Diagnosis: hematologic malignancies/disorders including aplastic anemia and
myelodysplastic syndrome

- Procedure: first allogeneic, T cell-replete transplantation of stem-cells from
peripheral blood or bone marrow of an human leukocyte antigen (HLA) matched, unrelated
or nonsyngeneic sibling donor

- CMV seropositive donor and/or recipient

- Performance level: must have already been determined to be eligible for HCT at City of
Hope (COH)

- Organ function requirements: The minimum organ function requirements should be the
same as the requirements for HCT

- Informed Consent: All patients must be capable of signing a written informed consent
and no consent can be provided by a legal guardian

Exclusion Criteria:

- The recipient had prior polymerase chain reaction (PCR) positive CMV infection in
blood or organ-specific disease in the past 12 months

- The source of hematopoietic stem cells is T-cell depleted

- Concomitant anti-graft-versus-host disease (GVD) treatment includes in vivo T cell
depletion

- Recipient is human immunodeficiency virus (HIV)-1 positive

- No prior allogeneic HCT (Allo HCT) (autologous HCT [Auto HCT] is allowed)