Children's Oncology Group
This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.
PRIMARY OBJECTIVE: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of imetelstat administered in combination with fludarabine and cytarabine to children with second or greater relapse of acute myeloid leukemia or first or greater relapse of myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML). SECONDARY OBJECTIVES: I. To define and describe the toxicities of imetelstat administered on this schedule in combination with fludarabine and cytarabine in patients with refractory and/or relapsed AML, MDS, or JMML. II. To characterize the…
Inclusion Criteria: * Patients must be ≥ 1 year and ≤ 18 years of age at the time of study enrollment * Patients, with or without down syndrome (DS), and with acute myeloid leukemia, therapy-related AML, MDS or JMML and meet one of the following: * Second or greater relapse or refractory AML, including isolated extramedullary disease (EMD), but excluding isolated central nervous system (CNS) or isolated testicular relapse * First or greater relapse of MDS * First or greater relapse of JMML * For flow cytometry, it's strongly recommended to enroll onto APAL2020SC or to send samples to H…
Undergo blood and CSF sample collection
Undergo bone marrow biopsy and aspiration
Undergo bone marrow biopsy and aspiration
Given IV and IT
Undergo ECHO
Given IV
Given IT
Given IV
Given IV or PO
Undergo lumbar puncture
Given IT