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RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Echocardiography Test
  • DRUG Cytarabine

Study Locations (18)

California

  • Children's Hospital of Orange County — Orange
  • UCSF Medical Center-Mission Bay — San Francisco

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia
  • Children's Hospital of Pittsburgh of UPMC — Pittsburgh

Alabama

  • Children's Hospital of Alabama — Birmingham

Colorado

  • Children's Hospital Colorado — Aurora

District of Columbia

  • Children's National Medical Center — Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta

Illinois

  • Lurie Children's Hospital-Chicago — Chicago

Indiana

  • Riley Hospital for Children — Indianapolis

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-02-04
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06247787

The ClinicalTrials.gov registry entry for NCT06247787 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Recurrent Childhood Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06247787 reports 18 study locations spanning 16 distinct geographic areas — top geographies include California, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06247787 about?

NCT06247787 is a clinical study titled "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". 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...

What is the current status of trial NCT06247787?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-02-04. Estimated completion is 2026-06-30.

What conditions does trial NCT06247787 study?

This clinical trial studies the following conditions: Recurrent Childhood Acute Myeloid Leukemia, Refractory Childhood Acute Myeloid Leukemia, Recurrent Childhood Myelodysplastic Syndrome, Recurrent Juvenile Myelomonocytic Leukemia, Refractory Childhood Myelodysplastic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06247787?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Echocardiography Test (PROCEDURE), Cytarabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06247787?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06247787 being conducted?

This trial has 18 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial