CancerNCT00079222
Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
A study testing itraconazole and voriconazole in people with Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- itraconazole and voriconazole
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1678
About this study
Official title: 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
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.
PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- itraconazole, voriconazole
- Keywords
- infection, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, untreated childhood acute lymphoblastic leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies, refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, accelerated phase chronic myelogenous leukemia, atypical chronic myeloid leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia
- Medical subject headings
- Neoplasms, Infections, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itraconazoleDrug
voriconazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2004 (estimated)
- Study startNov 2003
- Primary completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Mary C. Territo, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079222
- Sponsor's protocol ID
- CDR0000355116
- Other IDs
- UCLA-0307071
- Status last verified
- Jan 2013
- First submitted
- 8 Mar 2004
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00079222
- Acronym / sponsor ID
- CDR0000355116
- Conditions
- Cancer
- Keywords
- infection, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent childhood acute lymphoblastic leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Apr 2005 (actual)
- First posted
- 10 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation.
PURPOSE: This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| itraconazole | Drug | – |
| voriconazole | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary C. Territo, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing itraconazole and voriconazole in people with Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.