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
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 |
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
Are you between 1 and 18 years of age? |
Yes |
No |
Do you have de novo acute myeloid leukemia, therapy-related AML, myelodysplastic syndrome, or juvenile myelomonocytic leukemia? |
Yes |
No |
Do you have a second or greater relapse or refractory AML? |
Yes |
No |
Do you have a first or greater relapse of MDS? |
Yes |
No |
Do you have a first or greater relapse of JMML? |
Yes |
No |