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NCT06247787 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Recurrent Childhood Acute Myeloid Leukemia and Refractory Childhood Acute Myeloid Leukemia, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 18
- Study locations
NCT06247787 is a Phase 1 study of Recurrent Childhood Acute Myeloid Leukemia and Refractory Childhood Acute Myeloid Leukemia that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 36 participants, below the 53-participant average among 6 other Recurrent Childhood Acute Myeloid Leukemia trials with a reported enrollment target (32% lower). The trial reports 18 study locations across 16 states.
The verdict
NCT06247787, a Phase 1 study of Recurrent Childhood Acute Myeloid Leukemia and Refractory Childhood Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 18
- Study locations
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-02-04 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 53-participant average among 6 other Recurrent Childhood Acute Myeloid Leukemia trials with a reported enrollment target (32% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
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.
NCT06247787 reports 18 study locations spanning 16 distinct geographic areas - top geographies include California, Pennsylvania, Alabama.
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.
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).
Who is sponsoring clinical trial NCT06247787?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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.
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