Status:
ACTIVE_NOT_RECRUITING
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic/Lymphoid Cancer
Accelerated Phase Chronic Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Brief 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 manage...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the efficacy and safety of a individualized strategy for cytomegalovirus (CMV) preemptive management, one that monitors CMV viral load and clinical markers of immun...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01199562
Start Date
December 1 2010
End Date
December 15 2025
Last Update
July 16 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010