A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy

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, eit

Trial Details

NCT ID

NCT06247787

Phase

PHASE1

Sponsor

Children's Oncology Group

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Biospecimen Collection
Bone Marrow Aspiration
Bone Marrow Biopsy
Cytarabine
Echocardiography Test
Fludarabine

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Orange, California, United States|33.78779,-117.85311
San Francisco, California, United States|37.77493,-122.41942
Aurora, Colorado, United States|39.72943,-104.83192
Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility 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) o…
First or greater relapse of MDS

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →