Status:
COMPLETED
Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
Conditions:
Lymphoma
Infection
Eligibility:
All Genders
2+ years
Phase:
PHASE3
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 tra...
Detailed Description
BACKGROUND: Allogeneic blood and marrow transplant patients are highly susceptible to invasive fungal infection prior to engraftment, due to neutropenia and mucosal injury. After engraftment, an impa...
Eligibility Criteria
Inclusion
- 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)
- MDS, unclassified
- MDS associated with isolated del (5q)
- Chronic myelomonocytic leukemia (CMML)
- Lymphoma (including Hodgkin's) with chemosensitive disease (at least 50% response to chemotherapy) and receiving a related donor transplant
- Receiving myeloablative conditioning regimens
- Adequate physical function (cardiac, hepatic, renal, and pulmonary), within 6 weeks of initiation of conditioning (preferably within 4 weeks) unless otherwise specified
- Baseline galactomannan blood samples drawn within 30 days prior to randomization with the results available prior to randomization (72 hours prior to transplant)
- Chest computed tomography (CT) scans within 6 weeks prior to randomization if the results of the baseline galactomannan blood sample are not available prior to randomization (72 hours prior to transplant)
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00075803
Start Date
November 1 2003
End Date
September 1 2007
Last Update
January 4 2023
Active Locations (33)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UCSD Medical Center
La Jolla, California, United States, 92093
3
Stanford Hospital and Clinics
Stanford, California, United States, 94305
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010