Completed

Randomized Trial Of Safety And Tolerability Of Intravenous/Oral Voriconazole Versus Intravenous/Oral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients

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What is being tested

Data Collection

Who is being recruted

From 12 to 120 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2003
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: * Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation. OUTLINE: This is a randomized study. Patients are stratified according to donor type (related vs unrelated). Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning after allogeneic hematopoietic stem cell transplantation (AHSCT), patients receive voriconazole IV twice daily on days 1-14 and then orally\* twice daily on days 15-100. * Arm II: Beginning after AHSCT, patients receive itraconazole IV twice daily on days 1-2, once daily on days 3-14, and then orally\* twice daily on days 15-100. NOTE: \*Patients unable to tolerate oral medication may continue IV medication beyond day 14. In both arms, treatment continues in the absence of unacceptable toxicity or an invasive fungal infection. Patients requiring corticosteroid therapy for graft-versus-host disease continue to receive voriconazole or itraconazole beyond day 100. Patients are followed until day 180 post-transplantation. PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.

Official TitleRandomized Trial Of Safety And Tolerability Of Intravenous/Oral Voriconazole Versus Intravenous/Oral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients 
NCT00079222
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 12 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

DISEASE CHARACTERISTICS: * Undergoing allogeneic hematopoietic stem cell transplantation * No invasive yeast infection within the past 8 weeks * Colonized or superficial infection allowed * No documented or probable aspergillus or mold infection within the past 8 weeks * Patients with a history of candidemia must have negative blood cultures and no clinical signs of candidemia PATIENT CHARACTERISTICS: Age * 12 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective contraception * No prior allergy or intolerance to imidazoles or azoles (e.g., fluconazole, itraconazole, voriconazole, ketoconazole, miconazole, or clotrimazole) PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 1 week since prior amphotericin B or fluconazole for candidemia * No concurrent therapy with any of the following: * Rifampin * Rifabutin * Phenobarbital * Phenytoin * Carbamazepine * Oral midazolam * Triazolam * Terfenadine * Astemizole * Concurrent topical antifungal agents for superficial fungal infections allowed

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Jonsson Comprehensive Cancer Center, UCLALos Angeles, United StatesSee the location
CompletedOne Study Center
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