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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079222 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Drug: itraconazole Drug: voriconazole |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| 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 |
| Study Start Date: | January 2004 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No invasive yeast infection within the past 8 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapy with any of the following:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1678 | |
| Principal Investigator: | Mary C. Territo, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000355116, UCLA-0307071 |
| Study First Received: | March 8, 2004 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00079222 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia secondary myelodysplastic syndromes de novo myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable previously treated myelodysplastic syndromes chronic eosinophilic leukemia chronic idiopathic myelofibrosis |
|
Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Itraconazole Hydroxyitraconazole Pharmacologic Actions Lymphatic Diseases |
Antiparasitic Agents Neoplasms Therapeutic Uses Antifungal Agents Lymphoma, Large-Cell, Immunoblastic Voriconazole Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
