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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


N/A
12 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Mary C. Territo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000355116

NCT ID:

NCT00079222

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Cancer
  • 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
  • primary myelofibrosis
  • chronic neutrophilic leukemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent malignant testicular germ cell tumor
  • stage III malignant testicular germ cell tumor
  • recurrent ovarian epithelial cancer
  • stage II ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • poor prognosis metastatic gestational trophoblastic tumor
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • recurrent ovarian germ cell tumor
  • previously treated childhood rhabdomyosarcoma
  • recurrent childhood rhabdomyosarcoma
  • recurrent Wilms tumor and other childhood kidney tumors
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • juvenile myelomonocytic leukemia
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • childhood myelodysplastic syndromes
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781