Imetelstat Combination Therapy

A Phase 1 Study of GRN163L (Imetelstat) 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

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
36
Last Updated
1 month ago
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Participating Centers

There are 9 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Cytarabine is an antineoplastic chemotherapy agent that is FDA approved to treat several different kinds of leukemia.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Hydrocortisone is a corticosteroid that prevents the release of substances in the body that cause inflammation, and is given in conjunction with some cancer treatments.
  • Imetelstat is a first in class telomerase inhibitor that is being studied for use in several different cancers. 
  • Leucovorin is a form of folic acid that is typically given after certain types of chemotherapy to protect against side effects.
  • Methotrexate is a chemotherapy medication that may be used in the treatment of many different cancers.

Arms / Cohorts

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Accepting patients

Patients with Leukemia

Accepting patients

Patients with MDS

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