ACCL0933: Acute Myeloid Leukemia Fungal Infection Study (PRO00001576)

Full Name

ACCL0933: A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

 

Description

Before taking part in this study, participants will get cancer treatment for their AML that includes the use of chemotherapy. At the end of the first course of chemotherapy, participants will be randomized to receive one of the two antifungal drugs. Participants will be randomly assigned to one of two arms. In one of the arms, participants will receive fluconazole, which is the current standard treatment. In the other arm, participants will receive caspofungin, which is experimental. Participants have an equal chance of being assigned to the fluconazole or caspofungin arm. In addition to the main study, there are optional sub-studies. Participants can participate in the main study without participating in the optional sub-studies. One of the sub-studies is a genetic study.

 

Eligibility

Inclusion Criteria

Must be greater than or equal to 3 months and less than or equal to 30 years of age at the time of enrollment

Must have one of the following diagnoses and/or treatment plans: 1) newly diagnosed de novo AML; 2) first or subsequent relapse of AML; 3) Secondary AML; or 5) Treatment with institutional standard AML therapy in those without AML (for example, myelodysplastic syndrome, bone marrow blasts less than 5% or biphenotypia)

Must have adequate organ function as outlined in the protocol

Must not have acute promyelocytic leukemia (APL)

Must not have Down Syndrome

Must not have juvenile myelomonocytic leukemia (JMML)