Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial
Official title:
A Phase III Open-Label Trial of Caspofungin vs. Azole Prophylaxis for Patients at High-Risk for Invasive Fungal Infections (IFI) Following Allogeneic Hematopoietic Cell Transplantation (HCT)
Verified date | January 2022 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
Status | Completed |
Enrollment | 292 |
Est. completion date | September 30, 2021 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 20 Years |
Eligibility | Inclusion Criteria: - Age - For centers that will use fluconazole as the antifungal comparator: - Age >= 3 months and < 21 years - For centers that will use voriconazole as the antifungal comparator: - Age >= 2 years and < 21 years - The patient must be undergoing allogeneic HCT from any donor (including matched related) with any stem cell source for any underlying condition - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows: - 0.4 mg/dL (1 month to < 6 months of age) - 0.5 mg/dL (6 months to < 1 year of age) - 0.6 mg/dL (1 to < 2 years of age) - 0.8 mg/dL (2 to < 6 years of age) - 1.0 mg/dL (6 to < 10 years of age) - 1.2 mg/dL (10 to < 13 years of age) - 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age) - 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age) - Total bilirubin < 2.5 mg/dL unless the increase in bilirubin is attributable to Gilbert's syndrome - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x upper limit of normal (ULN) for age - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: - Within 90 days of enrollment: - Patients with a proven or probable invasive mold infection are not eligible - Patients with an incompletely treated invasive yeast infection are not eligible - Patients with an elevated galactomannan level (>= 0.5 index) within 30 days prior to time of enrollment (if performed) must have a full evaluation for invasive aspergillosis (including a negative chest computed tomography [CT] scan) during that time period to be eligible for enrollment - Patients receiving treatment for an IFI are not eligible - Patients with a history of echinocandin or azole hypersensitivity are not eligible - Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained - Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation - Lactating females are not eligible unless they have agreed not to breastfeed their infants |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Floating Hospital for Children at Tufts Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Norton Children's Hospital | Louisville | Kentucky |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
United States | Children's Hospital and Research Center at Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | Lucile Packard Children's Hospital Stanford University | Palo Alto | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Phoenix Childrens Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | UCSF Medical Center-Parnassus | San Francisco | California |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 100-day-cumulative Incidence of Proven or Probable IFI | Kaplan-Meier curves will be used to estimate the 100- day-cumulative incidence of proven/probable IFI following allogeneic HCT for patients randomized to the 2 arms. Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer (EORTC)/Mycoses Study Group (MSG). | Up to day 100 following allogeneic HCT | |
Other | Fungal-free-survival | Defined as time to death or proven/probable IFI during the first 42 days following allogeneic HCT. | Up to 42 days following allogeneic HCT | |
Other | Incidence of Overall Clinical GVHD Grades III and IV | The percentage distribution of overall clinical grades III and IV will be estimated for each arm. | Up to 100 days after allogeneic HCT | |
Other | Incidence of Overall Clinical GVHD Grades II to IV | The percentage distribution of overall clinical grades II and IV will be estimated for each arm. | Up to 100 days after allogeneic HCT | |
Other | Fungal-free-survival | Defined as time to death or proven/probable IFI during the first 100 days following allogeneic HCT. | Up to 100 days following allogeneic HCT | |
Other | Sensitivity of Beta-D Glucan Assay for the Diagnosis of IFI Using Fungitell Assay | Sensitivity of the beta-D glucan assay will be determined using standard formulas and EORTC/MSG criteria as the gold standard. | Up to day 42 following allogeneic HCT | |
Other | Specificity of Beta-D Glucan Assay for the Diagnosis of IFI Using Fungitell Assay | Specificity of the beta-D glucan assay will be determined using standard formulas and EORTC/MSG criteria as the gold standard. | Up to day 42 following allogeneic HCT | |
Other | Positive Predictive Value of Beta-D Glucan Assay for the Diagnosis of IFI Using Fungitell Assay | Positive predictive value of the beta-D glucan assay will be determined using standard formulas and EORTC/MSG criteria as the gold standard. | Up to day 42 following allogeneic HCT | |
Other | Negative Predictive Value of Beta-D Glucan Assay for the Diagnosis of IFI Using Fungitell Assay | Negative predictive value of the beta-D glucan assay will be determined using standard formulas and EORTC/MSG criteria as the gold standard. | Up to day 42 following allogeneic HCT | |
Primary | 42-day-cumulative Incidence of Proven or Probable Invasive Fungal Infections (IFI) | Kaplan-Meier curves will be used to estimate the 42- day-cumulative incidence of proven/probable IFI following allogeneic HCT for patients randomized to the 2 arms. Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer (EORTC)/Mycoses Study Group (MSG). | Up to 42 days following allogeneic HCT |
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