A Phase 1 study of GRN163L in combination with fludarabine and cytarabine for patients with acute myeloid leukemia that is in second or greater relapse or that is refractory to relapse therapy; myelodysplastic syndrome or juvenile myelomonocytic leukemia in first or greater relapse or is refractory to relapse therapy
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML
Sponsor: Children's Oncology Group
Enrolling: Male and Female Patients
IRB Number: AAAV5838
U.S. Govt. ID: NCT06247787
Contact: Nobuko Hijiya, MD: 2123059770 / nh2636@cumc.columbia.edu
Additional Study Information: This is a phase 1 study for participants with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or juvenile myelomonocytic leukemia (JMML) diagnosis. This study will observe the safety, side effects, and best dose of Imetelstat as an investigational drug, or drug that is not approved by the Food and Drug Administration (FDA), that can improve a disease or condition. Participants will receive Imeletstat intravenously (IV), and undergo study procedures such as blood and cerebrospinal fluid sample collection, as well imaging scans.
Investigator
Nobuko Hijiya, MD
Do You Qualify?
Is the patient (i.e. you or your child) between 1 year and 18 years of age? Yes No
Does the patient have a diagnosis of AML, MDS, or JMML? Yes No
Has the patient been enrolled in the screening study (APAL2020SC)? Yes No
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For more information, please contact:
Nobuko Hijiya, MD
nh2636@cumc.columbia.edu
2123059770