Clinical trial · Observational
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Modified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune Function
NCT01199562CI-TRIAL-00101762active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (154)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Acute Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiviral therapy | Procedure | — | UNRESOLVED |
| DNA analysis | Genetic | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| foscarnet sodium | Drug | — | UNRESOLVED |
| ganciclovir | Drug | — | UNRESOLVED |
| infection prophylaxis and management | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| polymerase chain reaction |
Design
Arms and outcomes
Arms (1)
- label
- Arm I
- description
- Patients receive standard antiviral infection prophylaxis and management comprising ganciclovir, valganciclovir, or foscarnet sodium for 2 weeks or until the plasma CMV DNA Q-PCR is negative. Patients may receive additional courses based on subsequent CMV reactivations.
- interventionNames
- Procedure: infection prophylaxis and management
- Other: laboratory biomarker analysis
- Other: flow cytometry
- Genetic: DNA analysis
- Genetic: RNA analysis
- Procedure: management of therapy complications
- Drug: ganciclovir
- Drug: valganciclovir
- Drug: foscarnet sodium
- Procedure: antiviral therapy
- Genetic: polymerase chain reaction
- Genetic: protein expression analysis
Primary outcomes (2)
- measure
- Initiation of anti-CMV therapy
- timeFrame
- Day 80 post stem cell transplant
- description
- Subjects will not be considered treated with anti-CMV agents unless at least 4 consecutive days of therapy are completed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.