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Home > "F" Clinical Trials Conditions > Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation  Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
For Condition: myelodysplastic and myeloproliferative disease,Acute Myeloid Leukemia,Chronic Myelogenous Leukemia,Infection,Acute Lymphocytic Leukemia
Status: Recruiting
Sponsor(s): Blood and Marrow Transplant Clinical Trials Network , National Heart, Lung, and Blood Institute (NHLBI),National Cancer Institute (NCI)
Synopsis: RATIONALE: Antifungals, such as fluconazole and voriconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic peripheral stem cell or bone marrow transplantation. It is not yet known whether fluconazole is more effective than voriconazole in preventing fungal infections in patients who are undergoing allogeneichematopoietic transplantation. PURPOSE: Randomizedphase III trial to compare the effectiveness of fluconazole with that of voriconazole in preventing invasive fungal infections in patients who are undergoing allogeneic hematopoietic transplantation.
Details: OBJECTIVES: Primary - Compare the efficacy of fluconazole vs voriconazole in preventing fungal infections in patients undergoing allogeneic hematopoietic transplantation. - Compare fungal-free survival rates at 180 days in patients treated with these regimens. Secondary - Compare invasive fungal infection rates in patients treated with these regimens. - Compare overall mortality due to fungal infection in patients treated with these regimens. - Compare engraftment rates and acute and chronic graft-versus-host disease rates in patients treated with these regimens. - Compare reasons for failure (e.g., plasma concentrations, tolerance, or fungal sensitivity) in patients treated with these regimens. - Compare the safety of these regimens in these patients. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center and donor type (sibling vs unrelated). Patients are randomized to 1 of 2 treatment arms. - Arm I: Beginning on the day of transplantation, patients receive oral fluconazole once daily and oral placebo once daily on days 0-100. - Arm II: Beginning on the day of transplantation, patients receive oral voriconazole twice daily on days 0-100. On either arm, patients may receive study drug IV if oral administration is not possible. In both arms, treatment continues in the absence of fungal infection or unacceptable toxicity. Patients are followed for 1 year. PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Acute myeloid leukemia - History of myelodysplastic syndromes (MDS) allowed - In first or second complete remission (less than 5% blasts) OR in early relapse (less than 30% blasts in bone marrow and no circulating blasts in peripheral blood without treatment) - Acute lymphoblastic leukemia - In first or second complete remission (less than 5% blasts) - Chronic myelogenous leukemia - Chronic or accelerated phase - MDS of one of the following subtypes: - Refractory anemia (RA) - RA with ringed sideroblasts - Refractory cytopenia with multilineage dysplasia - Refractory cytopenia with multilineage dysplasia and ringed sideroblasts - RA with excess blasts (RAEB)-1 (5-10% blasts) - RAEB-2 (10-20% blasts) - MDS, unclassified - MDS associated with isolated del(5q) - Receiving an allogeneic peripheral blood or marrow transplantation from a family or unrelated donor OR receiving a cord blood transplantation from a sibling or other donor (for children under age 12) - Must have a HLA 6/6 matched donor - Receiving a myeloablative conditioning regimen PATIENT CHARACTERISTICS: Age - 2 and over Performance status - Karnofsky 70-100% OR - Lansky 50-100% (for patients under age 16) Life expectancy - Not specified Hematopoietic - Not specified Hepatic - ALT 5 times upper limit or normal - Bilirubin 2.5 mg/dL Renal - Creatinine normal for age OR - Creatinine clearance > 50% of lower limit of normal for age Cardiovascular - Asymptomatic* - No prolonged QTc syndrome NOTE: *If symptomatic, must have LVEF > 40% at rest that improves with exercise OR shortening fraction > 26%. Pulmonary - DLCO, FEV - , and FVC > 45% of predicted OR - Oxygen saturation > 85% on room air Immunologic - No history of allergy or intolerance to azoles (e.g., fluconazole, itraconazole, voriconazole, posaconazole, ketoconazole, miconazole, or clotrimazole) - No invasive yeast infection within the past 8 weeks - Colonized or superficial infection allowed - No candidemia within the past 8 weeks - Patients with candidemia more than 8 weeks prior to study entry must meet all of the following criteria: - Negative blood culture within the past 14 days - No clinical signs of candidemia - Not receiving antifungal therapy for candidemia - No proven or probable aspergillus or other mold infection or deep mycoses (including hepatosplenic candidiasis) within the past 4 months - No uncontrolled viral or bacterial infection - HIV negative Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic or autologous transplantation - No concurrent routine granulocyte transfusions Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No more than 3 days of rifampin or carbamazepine treatment within the past 7 days - No concurrent therapy with any of the following: - Rifampin - Rifabutin - Carbamazepine - Cisapride - Terfenadine - Astemizole - Ergot alkaloids - Long-acting barbiturates - Sirolimus - Quinidine - Pimozide - Dofetilide - Nebulized or inhaled amphotericin - Therapeutic anticoagulation with warfarin - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnWingard, Study Chair, Shands Cancer Center at the University of Florida Health Science Center
Children's Hospital Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Leslie Lehmann 617-632-4932
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Kieren Marr 206-667-2995
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Sergio Giralt 713-794-5745
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Reggie Duerst 773-975-8512
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Naynesh Kamani 202-884-2169
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Steven Devine 314-935-5000
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Hillard Lazarus 216-844-3629
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Richard Jones 410-955-2006
Cardinal Glennon Children's Hospital *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Michael Kelly 314-577-5638
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lindsey Baden 617-732-8881
St. Louis Children's Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Shalini Shenoy 314-454-6018
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Donna Salzman 205-934-1908
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Edward Stadtmauer 215-662-7910
Texas Transplant Institute *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Michael Grimley 210-575-8500
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92037-0960
United States
Recruiting Edward Ball 858-657-7058
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting James Ito 626-359-8111
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037-1027
United States
Recruiting James Mason 858-554-8597
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0922
United States
Recruiting Voravit Ratanatharathorn 734-936-8785
Kansas City Cancer Centers - Central *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Joseph McGuirk 816-531-1471
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6310
United States
Recruiting Haydar Frangoul 615-936-1762
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting John Horan 585-275-1941
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Paul Haut 317-274-8784
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Kamar Godder 503-494-0829
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Joanne Kurtzberg 919-668-1119
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting John Wingard 352-846-2814
Children's Mercy Hospital *Recruiting*
Kansas City, Missouri, 64108
United States
Recruiting Alan Gamis 816-234-3265
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Joel Brochstein 201-996-5600
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5623
United States
Recruiting Janice Brown 650-723-6661
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Joanne Burik 612-625-8462
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-588-3498
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Trudy Small 212-639-5965
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-3330
United States
Recruiting Alison Freifeld 402-559-8650
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Luis Isola 212-241-6021
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting Kevin High 336-716-4584
Additional Information:
Study ID Numbers: CDR0000349374; FHCRC-1808.00,BMTCTN-0101,UF-G-074-2003
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075803
Other Acute Myeloid Leukemia Studies:
1. Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
2. The Epidemiology of Infection with Vancomycin-Resistant Enterococci
3. Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
4. Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
5. Infection and Cardiovascular Disease
Related Studies:
Other Acute Myeloid Leukemia Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
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