Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)
A Randomized Double-blind Trial of Fluconazole Versus Voriconazole for the Prevention of Invasive Fungal Infections in Allogeneic Blood and Marrow Transplant Patients (BMT CTN #0101)
4 other identifiers
interventional
600
1 country
33
Brief Summary
The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 lymphoma
Started Nov 2003
Shorter than P25 for phase_3 lymphoma
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 9, 2004
CompletedFirst Posted
Study publicly available on registry
January 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedResults Posted
Study results publicly available
September 4, 2015
CompletedJanuary 4, 2023
December 1, 2022
2.8 years
January 9, 2004
February 22, 2013
December 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant
180 days
Secondary Outcomes (12)
Frequency of Invasive Fungal Infections (IFI)
1 year
Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days
100, 180, and 365 days
Overall Survival
100, 180, and 365 days
Relapse Free Survival
100, 180, and 365 days
Frequency of Use of Amphotericin B or Caspofungin
1 year
- +7 more secondary outcomes
Study Arms (2)
Fluconazole
ACTIVE COMPARATORThe dose of fluconazole is 400 mg by mouth or intravenous drip.
Voriconazole
EXPERIMENTALThe dose of oral voriconazole is 200 mg twice daily. When voriconazole must be given intravenously, it will be given at a dose of 200 mg every 12 hours for the duration of intravenous therapy.
Interventions
Fluconazole will be administered orally once daily. Fluconazole capsules should be taken at least one hour before or one hour after a meal. If oral drug is not possible, it will be given intravenously once daily in a total volume of 200 mL in patients \> 12 years. For adults, each 200 mL infusion will be administered over 2 hours. In patients \< 12 years, intravenous doses will be prepared.
Voriconazole will be administered orally twice daily. Voriconazole capsules should be taken at least one hour before or one hour after a meal. Taken concomitantly with food, bioavailability of voriconazole is reduced. If oral drug is not possible, it will be given intravenously at a dosage of 200 mg every 12 hours over two hours in patients \> 12 years. Each voriconazole dose will be diluted to a total volume of 200 mL in patients \> 12 years. Volumes of the formulation required to provide 4 mg/kg doses for children age \< 12 years.
Eligibility Criteria
You may qualify if:
- Must receive an allogeneic peripheral blood or marrow transplant from a family or unrelated donor, or for children under the age of 12, a cord blood transplant from either a sibling or other donor
- Must have a 5 or 6 of 6 human leukocyte antigens (HLA)-matched donor. The match may be determined at serologic level for HLA-A and HLA-B loci. For sibling donors, matching may be determined at serologic level for HLA-DR; for unrelated donors, matching for HLA-DRB1 must be at the high-resolution molecular level
- Must have one of the following underlying diseases:
- Acute myelogenous leukemia (AML)
- Acute lymphocytic leukemia (ALL)
- Acute undifferentiated leukemia (AUL)
- Acute biphenotypic leukemia in first or second complete remission
- Chronic myelogenous leukemia (CML) in either chronic or accelerated phase
- One of the following myelodysplastic syndrome(s) (MDS):
- Refractory anemia
- Refractory anemia with ringed sideroblasts
- Refractory cytopenia with multilineage dysplasia
- Refractory cytopenia with multilineage dysplasia and ringed sideroblasts
- Refractory anemia with excess blasts-1 (5-10% blasts)
- Refractory anemia with excess blasts-2 (10-20% blasts)
- +8 more criteria
You may not qualify if:
- Invasive yeast infection within the 8 weeks prior to conditioning regimen initiation. Patients are eligible if colonized or have had superficial infection. Patients with a history of candidemia greater than 8 weeks prior to conditioning must have a negative blood culture within 14 days of conditioning (within 7 days is recommended), no clinical signs of candidemia, and may not still require antifungal therapy
- Presumptive, proven, or probable aspergillus or other mold infection or deep mycoses (including hepatosplenic candidiasis) within 4 months prior to conditioning regimen initiation
- Uncontrolled viral or bacterial infection at the time of study registration
- Pregnant or breastfeeding. Women of child-bearing age must avoid becoming pregnant while receiving antifungal agents
- Karnofsky performance status less than 70% or Lansky status less than 50% for patients under 16 years old unless approved by the medical monitor or protocol chair
- History of allergy or intolerance to azoles (e.g., fluconazole, itraconazole, voriconazole, posaconazole, ketoconazole, miconazole, clotrimazole)
- Requiring therapy with rifampin, rifabutin, carbamazepine, cisapride (Propulsid®), terfenadine (Seldane®), astemizole (Hismanal®), ergot alkaloids, long-acting barbiturates, or who have received more than 3 days treatment with rifampin or carbamazepine within 7 days prior to conditioning regimen initiation. Patients on therapeutic anticoagulation with coumadin (1 mg/day for port prophylaxis is permitted)
- Receiving sirolimus
- Prolonged QTc syndrome at study entry
- HIV positive
- Receiving another investigational drug unless cleared by the medical monitors
- Received a prior allogeneic or autologous transplant
- Active central nervous system disease
- On fungal prophylaxis during conditioning regimen (it is recommended that fungal prophylaxis be suspended once patient is enrolled)
- Prior cancer, other than resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the medical monitor or protocol chair. Cancer previously treated with curative intent over 5 years ago will be allowed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Blood and Marrow Transplant Clinical Trials Networkcollaborator
- National Cancer Institute (NCI)collaborator
- National Marrow Donor Programcollaborator
Study Sites (33)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCSD Medical Center
La Jolla, California, 92093, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Johns Hopkins/SKCCC
Baltimore, Maryland, 21231, United States
Dana Farber Cancer Institute/Brigham & Womens
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute/Children's Hospital of Boston
Boston, Massachusetts, 02114, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute/BMT
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Kansas City Cancer Centers
Kansas City, Missouri, 64111, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63110, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University/St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Texas/MD Anderson CRC
Houston, Texas, 77030, United States
Texas Transplant Institute
San Antonio, Texas, 78229, United States
Utah BMT/Univ of Utah Med School
Salt Lake City, Utah, 84132, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (2)
Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, Baden LR, Gersten ID, Mendizabal AM, Leather HL, Confer DL, Maziarz RT, Stadtmauer EA, Bolanos-Meade J, Brown J, Dipersio JF, Boeckh M, Marr KA; Blood and Marrow Transplant Clinical Trials Network. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood. 2010 Dec 9;116(24):5111-8. doi: 10.1182/blood-2010-02-268151. Epub 2010 Sep 8.
PMID: 20826719RESULTMauskopf J, Chirila C, Graham J, Gersten ID, Leather H, Maziarz RT, Baden LR, Bolanos-Meade J, Brown JM, Walsh TJ, Horowitz MH, Kurtzberg J, Marr KA, Wingard JR. Comparative cost-effectiveness analysis of voriconazole and fluconazole for prevention of invasive fungal infection in patients receiving allogeneic hematopoietic cell transplants. Am J Health Syst Pharm. 2013 Sep 1;70(17):1518-27. doi: 10.2146/ajhp120599.
PMID: 23943184RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nancy DiFronzo, PhD
- Organization
- NHLBI
Study Officials
- STUDY DIRECTOR
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2004
First Posted
January 13, 2004
Study Start
November 1, 2003
Primary Completion
September 1, 2006
Study Completion
September 1, 2007
Last Updated
January 4, 2023
Results First Posted
September 4, 2015
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will share