Clinical trial · Interventional
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
A Phase III Multicenter Study of Cytomegalovirus Prophylaxis With Valacyclovir for the Prevention of Serious Fungal and Bacterial Infections Among Cytomegalovirus Seronegative Recipients of Cytomegalovirus Seropositive Sx Stem Cell Transplants
- 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: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation. PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acyclovir | Drug | — | UNRESOLVED |
| acyclovir sodium | Drug | — | UNRESOLVED |
| valacyclovir | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Disease requiring one of the following types of stem cell transplantation:
* First myeloablative allogeneic peripheral blood stem cell
* Unrelated cord blood
* Bone marrow
* Related or unrelated donor
* T-cell depleted or non-T-cell depleted
* CD34 selected or non-selected
* Patient must be cytomegalovirus (CMV)-seronegative and donor must be CMV-seropositive
* No transplantation with nonmyeloablative regimens, including any of the following:
* Fludarabine and total body irradiation (TBI) (2 Gy or less)
* TBI alone (2 Gy)
* Fludarabine, cytarabine, and idarubicin
* Fludarabine and melphalan (140 mg/m\^2 or less)
* No definite or probable pre-transplantation diagnosis of invasive mold infection (aspergillosis, fusariosis, or zygomycosis), including pulmonary or hepatic nodules consistent with invasive mold infection for which patients are receiving targeted prophylaxis with amphotericin or other mold-active products
* No pre-transplantation-CMV disease (gastrointestinal or pneumonia)
PATIENT CHARACTERISTICS:
Age
* 12 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* HIV negative
* No hypersensitivity to acyclovir or valacyclovir
* Not pregnant
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available