Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT00016068
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Have undergone allogeneic peripheral blood stem cell, cord blood, or marrow transplantation (related or unrelated, T-cell depleted or non-T-cell depleted, CD34-selected or non-selected, or myeloablative or non-myeloablative) within the past 80-120 days
* Positive pre-transplantation cytomegalovirus (CMV) serology of recipient and/or donor
* Seropositive recipients with one of the following:
* CMV infection before day 80, as determined by:
* pp65 antigenemia
* CMV DNA in plasma
* Peripheral blood leukocytes (PBL) or whole blood at any level detected by polymerase chain reaction or hybrid capture
* CMV pp67 mRNA
* CMV viremia by blood culture
* Surveillance bronchoalveolar lavage (culture or cytology)
* CMV disease more than 6 weeks prior to enrollment
* Presence of graft-versus-host disease (GVHD) at enrollment
* Acute GVHD that requires treatment with systemic corticosteroids of doses greater than 0.5 mg/kg OR
* Chronic clinically extensive GVHD requiring treatment with corticosteroids
* Continuous prophylaxis with ganciclovir, foscarnet, or cidofovir between engraftment and day 80 OR
* Seronegative recipient with seropositive donor who has CMV infection before day 80
* No rising or uncontrolled CMV load (pp65 antigenemia levels no greater than 1/slide or no greater than 100 copies of CMV DNA per mL of plasma or per million PBL allowed)
* No CMV disease within 6 weeks prior to randomization
* No leukemic relapse
* Cytogenetic or molecular relapse allowed
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Not specified
Life expectancy:
* At least 2 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3 for at least 1 week prior to enrollment
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 2.5 mg/mL
Other:
* No hypersensitivity to ganciclovir or valganciclovir
* No uncontrolled diarrhea or severe gastrointestinal disease that would preclude oral medication
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 90 days after study participation
* HIV negative
* Proficient in English
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* Not specified
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* Prior ganciclovir, foscarnet, cidofovir, high-dose acyclovir, or valacyclovir as prophylaxis or preemptive therapy allowed
* No concurrent prophylactic foscarnet, cidofovir, or ganciclovir (IV or oral)
* No concurrent prophylactic high-dose acyclovir (more than 800 mg twice daily), valacyclovir (more than 500 mg twice daily), cidofovir (more than 0.5 mg/kg per week), or famciclovir (more than 500 mg/day) except for limited treatment courses at higher doses for varicella-zoster virus infections
* Concurrent low-dose (≤ 0.5 mg/kg per week) cidofovir allowed for limited treatment courses
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00016068
Study Brief:
Protocol Section:
NCT00016068