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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

NCT06247787 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Myelodysplastic Syndrome
  • Recurrent Juvenile Myelomonocytic Leukemia
  • Refractory Childhood Acute Myeloid Leukemia
  • Refractory Childhood Myelodysplastic Syndrome
  • Refractory Juvenile Myelomonocytic Leukemia

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

Given IT

BIOLOGICAL

Imetelstat

Given IV

DRUG

Leucovorin Calcium

Given IV or PO

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Methotrexate

Given IT

Sponsors & Collaborators

  • Geron Corporation

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Alexandra M Stevens · Pediatric Early Phase Clinical Trial Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-04
Primary Completion
2028-03-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247787 on ClinicalTrials.gov