Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

NCT00016068 | Completed Phase 3

• 4 other identifiers: 1577.00FHCRC-1577.00MSKCC-01127NCI-H01-0072
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus. PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation.

Conditions

Infection

Keywords

infection

Outcome Measures

Primary Outcomes (1)

• Late cytomegalovirus infection by plasma PCR positivity

Interventions

ganciclovir DRUG

valganciclovir DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

• Boeckh M, Nichols WG, Chemaly RF, Papanicolaou GA, Wingard JR, Xie H, Syrjala KL, Flowers ME, Stevens-Ayers T, Jerome KR, Leisenring W. Valganciclovir for the prevention of complications of late cytomegalovirus infection after allogeneic hematopoietic cell transplantation: a randomized trial. Ann Intern Med. 2015 Jan 6;162(1):1-10. doi: 10.7326/M13-2729.

  PMID: 25560711 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Ganciclovir; Valganciclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Boeckh, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Study Completion: September 1, 2007
• Last Updated: May 17, 2010

Record last verified: 2010-05

Locations

US (7)