Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
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)
6 other identifiers
interventional
292
2 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2013
Longer than P75 for phase_3
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2012
CompletedStudy Start
First participant enrolled
March 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedResults Posted
Study results publicly available
January 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedOctober 16, 2024
October 1, 2024
6.8 years
January 1, 2012
December 10, 2020
October 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (9)
100-day-cumulative Incidence of Proven or Probable IFI
Up to day 100 following allogeneic HCT
Fungal-free-survival
Up to 42 days following allogeneic HCT
Incidence of Overall Clinical GVHD Grades III and IV
Up to 100 days after allogeneic HCT
- +6 more other outcomes
Study Arms (2)
Arm I (caspofungin acetate)
EXPERIMENTALPatients receive caspofungin acetate IV over 1 hour once daily (QD) beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.
Arm II (fluconazole or voriconazole)
ACTIVE COMPARATORPatients receive fluconazole IV over 1-2 hours QD or PO QD; or voriconazole IV over 1-2 hours QD or PO BID beginning within 24 hours of allogeneic HSCT (day -1 or 0) and continuing until day 42 in the absence of invasive fungal infections or disease progression.
Interventions
Optional correlative studies
Eligibility Criteria
You may qualify if:
- 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:
- mg/dL (1 month to \< 6 months of age)
- mg/dL (6 months to \< 1 year of age)
- mg/dL (1 to \< 2 years of age)
- mg/dL (2 to \< 6 years of age)
- mg/dL (6 to \< 10 years of age)
- mg/dL (10 to \< 13 years of age)
- mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (49)
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
Dvorak CC, Fisher BT, Esbenshade AJ, Nieder ML, Alexander S, Steinbach WJ, Dang H, Villaluna D, Chen L, Skeens M, Zaoutis TE, Sung L. A Randomized Trial of Caspofungin vs Triazoles Prophylaxis for Invasive Fungal Disease in Pediatric Allogeneic Hematopoietic Cell Transplant. J Pediatric Infect Dis Soc. 2021 Apr 30;10(4):417-425. doi: 10.1093/jpids/piaa119.
PMID: 33136159DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher C Dvorak
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2012
First Posted
January 4, 2012
Study Start
March 21, 2013
Primary Completion
December 31, 2019
Study Completion
September 30, 2021
Last Updated
October 16, 2024
Results First Posted
January 7, 2021
Record last verified: 2024-10