ACCL1131, 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)

Summary

Participants will receive their planned SCT conditioning regimen that includes high doses of chemotherapy or radiation. Taking part in this study will not change the cancer treatment plan.

Before the SCT conditioning regimen is completed, all eligible and consenting participants will be randomized to receive one of two antifungal drugs:
-- azole antifungal arm [?] Current standard treatment. Participants will receive Fluconazole or Voriconazole by infusion in a vein over 1-2 hours (or longer) or by mouth.
-- Caspofungin arm [?] experimental treatment. Participants will receive Caspofungin by infusion in a vein over 1 hour. The dose on the first day is different from the dose given in the days that follow.

all participants will begin receiving their assigned antifungal drug on the day of the SCT (called Day 0) and until Day 42 or discharge from the hospital.

Participant Eligibility

1. 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.
2. Diagnosis
- The patient must be undergoing allogeneic HCT for treatment of a malignancy, bone marrow
failure syndrome, or congenital immunodeficiency.
- The source for allogeneic stem cells (bone marrow, peripheral blood stem cells, or umbilical cord
blood) must be an unrelated donor or mismatched (<= 7/8 at HLA-A, B, C, DR if bone marrow or
PBSC; <= 5/6 at HLA-A, B, DR if cord blood) family donor.
3. Performance Level
Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients <= 16 years of age.
See https://members.childrensoncologygroup.org/prot/reference_materials.asp under Standard Sections for Protocols.
4. Organ Function Requirements
-- Adequate Renal Function based on Creatinine clearance or radioisotope GFR or A serum creatinine
-- Adequate Liver Function Defined As:
- Total bilirubin <= 1.5 x upper limit of normal (ULN) for age (unless the increase in bilirubin is
attributable to Gilbert[Single Quote]s Syndrome), and
- SGOT (AST) or SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age.