RecruitingPhase IEN originalLeukemia

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 is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About 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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek od 1 roku do 18 lat w momencie włączenia do badania
  • Rozpoznanie białaczki mieloidalnej (w tym związanej z poprzednim leczeniem), zespołu mielodysplastycznego lub choroby mielomononuklearnej, w tym z zespołem Downa
  • Druga lub kolejna nawrót białaczki mieloidalnej, lub choroba oporyczna na leczenie
  • Pierwsza lub kolejna nawrót zespołu mielodysplastycznego
  • Pierwsza lub kolejna nawrót choroby mielomononuklearnej
  • Badania szpiku kości wykazujące obecność atypowych komórek białaczkowych w określonym procencie

Simplified criteria — AI translation

Trial details

Minimum age
1 Year
Maximum age
18 Years
Last updated (source)
August 25, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (19)

Children's Hospital of Alabama

Birmingham, United States

Children's Hospital of Orange County

Orange, United States

UCSF Medical Center-Mission Bay

San Francisco, United States

Children's Hospital Colorado

Aurora, United States

Children's National Medical Center

Washington D.C., United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, United States

Lurie Children's Hospital-Chicago

Chicago, United States

Riley Hospital for Children

Indianapolis, United States

Dana-Farber Cancer Institute

Boston, United States

C S Mott Children's Hospital

Ann Arbor, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, United States

Washington University School of Medicine

St Louis, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, United States

Children's Hospital of Philadelphia

Philadelphia, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, United States

Saint Jude Children's Research Hospital

Memphis, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, United States

Seattle Children's Hospital

Seattle, United States

Trial contact

Girish Dhall

PRINCIPAL_INVESTIGATOR

Elyssa M. Rubin

PRINCIPAL_INVESTIGATOR

Kieuhoa T. Vo

PRINCIPAL_INVESTIGATOR

Margaret E. Macy

PRINCIPAL_INVESTIGATOR

AeRang Kim

PRINCIPAL_INVESTIGATOR

Jason R. Fangusaro

PRINCIPAL_INVESTIGATOR

Site Public Contact

Sara Zarnegar-Lumley

PRINCIPAL_INVESTIGATOR

Site Public Contact

Brian D. Weiss

PRINCIPAL_INVESTIGATOR

Site Public Contact

Jonathan Paolino

PRINCIPAL_INVESTIGATOR

Site Public Contact

Rajen Mody

PRINCIPAL_INVESTIGATOR

Site Public Contact

Robin L. Williams

PRINCIPAL_INVESTIGATOR

Shalini Shenoy

PRINCIPAL_INVESTIGATOR

Nobuko Hijiya

PRINCIPAL_INVESTIGATOR

Site Public Contact

Joseph G. Pressey

PRINCIPAL_INVESTIGATOR

Sarah K. Tasian

PRINCIPAL_INVESTIGATOR

Andrew Bukowinski

PRINCIPAL_INVESTIGATOR

Matthew Rees

PRINCIPAL_INVESTIGATOR

Site Public Contact

Alexandra M. Stevens

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/26/2026.

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