Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia



Status:Completed
Conditions:Blood Cancer, Infectious Disease, Women's Studies, Hematology, Leukemia
Therapuetic Areas:Hematology, Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:Any - 30
Updated:2/17/2019
Start Date:April 4, 2011
End Date:June 30, 2018

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A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in
preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid
leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults
with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for
prophylaxis in children is not known. Caspofungin has activity against yeast and some molds
while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that
agents with activity against yeasts and molds are more effective than those with just
activity against yeasts. There are limited data to answer this comparative question in
children. This study will establish much needed pediatric data to guide clinical decision
making on optimal antifungal prophylaxis.

PRIMARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin administered during periods of neutropenia
following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence
of proven or probable invasive fungal infections (IFI) compared with fluconazole.

SECONDARY OBJECTIVES:

I. To determine if prophylaxis with caspofungin will result in a lower incidence of proven or
probable cases of invasive aspergillosis (IA) compared with fluconazole. (Clinical) II. To
determine if prophylaxis with caspofungin will result in improved survival compared to
fluconazole. (Clinical) III. To determine if prophylaxis with caspofungin will result in less
empiric antifungal therapy compared to fluconazole. (Clinical) IV. To determine the
sensitivity, specificity, and positive and negative predictive value of biweekly
galactomannan (GM) and beta-D glucan testing in diagnosing IFI. (Biological) V. To test the
association between single nucleotide polymorphisms (SNPs) in genes involved in innate
immunity and proven or probable IFI. (Biological) VI. To develop predictive models of IFI
using SNP in genes involved in immunity and clinical covariates. (Biological)

OUTLINE: Patients are randomized to one of two treatment arms during their first chemotherapy
course for AML.

ARM I: Patients receive caspofungin acetate intravenously (IV) over one hour once daily (QD)
beginning within 24-72 hours following the last dose of chemotherapy for each course. and
continuing until absolute neutrophil count (ANC) > 100-500/uL following the nadir or the next
chemotherapy course begins.

ARM II: Patients receive fluconazole IV over 1-2 hours or orally (PO) QD beginning within
24-72 hours following the last dose of chemotherapy for each course.

Protocol prophylaxis was continued in both arms, until ANC increased to > 100-500/uL
following the nadir or the next chemotherapy course began. Prophylaxis was given for all
courses of planned AML chemotherapy or until the patient met one of the following
off-protocol therapy criteria: development of proven or probable IFI according to
institutional diagnosis, initiation of conditioning for hematopoietic cell transplantation,
initiation of a new chemotherapy regimen for relapsed or refractory AML, refusal of further
protocol therapy by patient, parent or guardian, or physician determines it is in the best
interest of the patient.

Regardless of duration of prophylaxis, subjects in both arms are monitored for IFI until the
earliest of the following criteria is met: two weeks after recovery of neutropenia following
the last planned AML chemotherapy course, initiation of conditioning for hematopoietic cell
transplantation, initiation of a new chemotherapy regimen for relapsed or refractory AML,
withdrawal of consent for any further data submission, or death.

Patients were followed for overall survival up to two years from enrollment.

Inclusion Criteria:

- Patients must have one of the following diagnoses and/or treatment plans:

- Newly diagnosed de novo AML

- First or subsequent relapse of AML

- Secondary AML

- Treatment with institutional standard AML therapy in those without AML (for
example, myelodysplastic syndrome, bone marrow blasts > 5% or biphenotypia)

- Note: Patients with a history of prolonged antifungal therapy (example, relapsed
AML) are eligible

- 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 (age 1 month to < 6 months)

- =< 0.5 mg/dL (age 6 months to < 1 year)

- =< 0.6 mg/dL (age 1 to < 2 years)

- =< 0.8 mg/dL (age 2 to < 6 years)

- =< 1 mg/dL (age 6 to < 10 years)

- =< 1.2 mg/dL (age 10 to < 13 years)

- =< 1.4 mg/dL (females age >= 13 years)

- =< 1.5 mg/dL (males age 13 to < 16 years)

- =< 1.7 mg/dL (males age >= 16 years)

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age AND Serum glutamic
oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate
pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age

- All patients and/or their parents or legal guardians must sign a written informed
consent

Exclusion Criteria:

- Patients with the following diagnoses are not eligible:

- Acute promyelocytic leukemia (APL)

- Down syndrome

- Juvenile myelomonocytic leukemia (JMML)

- Patients with a documented history of invasive fungal infection (IFI) within the
previous 30 days are not eligible

- Patients with a history of echinocandin or fluconazole hypersensitivity are not
eligible

- Patients receiving treatment for an IFI are not eligible

- Female patients of childbearing age must have a negative pregnancy test

- Patients must agree to use an effective birth control method

- Lactating patients must agree not to nurse a child while on this trial
We found this trial at
167
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Koh B. Boayue
Phone: 505-272-6972
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Philip M. Monteleone
Phone: 484-884-2201
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Alyssa T. Reddy
Phone: 205-934-0309
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Martin L. Brecher
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: John P. Perentesis
Phone: 513-636-2799
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Yousif (Joe) H. Matloub
Phone: 216-844-5437
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A. Ranalli
Phone: 614-722-2708
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Principal Investigator: M. C. Johnson
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Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Marshall A. Schorin
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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9981 S Healthpark Dr # 465
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3551 Roger Brooke Dr
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100 Michigan Street Northeast
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2500 N State St
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4650 Sunset Blvd
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 (323) 660-2450
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4015 22nd Place
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601 Children's Lane
Norfolk, Virginia 23507
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
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1717 South Orange Avenue # 100
Orlando, Florida 32806
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5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Principal Investigator: Jeffrey H. Schwartz
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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593 Eddy Street
Providence, Rhode Island 02903
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401 College Street
Richmond, Virginia 23298
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
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1 Tampa General Cir
Tampa, Florida 33606
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40 Sunshine Cottage Road
Valhalla, New York 10595
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
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Akron, Ohio 44308
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Albany, New York 12208
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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Asheville, North Carolina 28801
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Atlanta, Georgia 30322
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
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22 South Greene Street
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489 State St
Bangor, Maine 04401
(207) 973-7000
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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100 E Idaho St
Boise, Idaho 83712
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Boston, Massachusetts 02111
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Bronx, New York 10467
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Calgary, Alberta
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60614
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
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5841 S Maryland Ave
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2049 E 100th St
Cleveland, Ohio 44106
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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100 North Academy Avenue
Danville, Pennsylvania 17822
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4160 John R St #2122
Detroit, Michigan 48201
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Downey, California 90242
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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East Lansing, Michigan 48824
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801 Broadway North
Fargo, North Dakota 58122
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
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1600 Southwest Archer Road
Gainesville, Florida 32610
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Green Bay, Wisconsin 54301
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Mauro Grossi
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
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BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Houston, TX
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Robert J. Fallon
Phone: 317-274-2552
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, IN
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Indianapolis, Indiana 46260
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Iowa City, IA
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Jacksonville, Florida 32207
Principal Investigator: Eric S. Sandler
Phone: 904-697-3529
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Jacksonville, FL
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Kalamazoo, Michigan 49008
Principal Investigator: Jeffrey S. Lobel
Phone: 800-227-2345
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Kalamazoo, MI
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Kansas City, Missouri 64108
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Kansas City, MO
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Las Vegas, Nevada 89144
Principal Investigator: Jonathan Bernstein
Phone: 702-384-0013
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Las Vegas, NV
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Principal Investigator: Jonathan Bernstein
Phone: 702-384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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Las Vegas, NV
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Las Vegas, Nevada 89109
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Sara Chaffee
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Lexington, KY
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