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

Summary

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.

Description

Eligibility

Age range

1–18 years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Biospecimen Collection

  Undergo blood and CSF sample collection

• Procedure
  Bone Marrow Aspiration

  Undergo bone marrow biopsy and aspiration

• Procedure
  Bone Marrow Biopsy

  Undergo bone marrow biopsy and aspiration

• Drug
  Cytarabine

  Given IV and IT

• Procedure
  Echocardiography Test

  Undergo ECHO

• Drug
  Fludarabine

  Given IV

• Drug
  Hydrocortisone Sodium Succinate

Locations (19)