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

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

February 4, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Recurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Myelodysplastic SyndromeRecurrent Juvenile Myelomonocytic LeukemiaRefractory Childhood Acute Myeloid LeukemiaRefractory Childhood Myelodysplastic SyndromeRefractory 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

Trial Locations (17)

10032

RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20010

RECRUITING

Children's National Medical Center, Washington D.C.

30329

RECRUITING

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

35233

SUSPENDED

Children's Hospital of Alabama, Birmingham

38105

RECRUITING

Saint Jude Children's Research Hospital, Memphis

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

RECRUITING

Riley Hospital for Children, Indianapolis

48109

RECRUITING

C S Mott Children's Hospital, Ann Arbor

55455

RECRUITING

University of Minnesota/Masonic Cancer Center, Minneapolis

60611

RECRUITING

Lurie Children's Hospital-Chicago, Chicago

63110

RECRUITING

Washington University School of Medicine, St Louis

77030

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

80045

RECRUITING

Children's Hospital Colorado, Aurora

92868

RECRUITING

Children's Hospital of Orange County, Orange

94158

RECRUITING

UCSF Medical Center-Mission Bay, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Geron Corporation

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT06247787 - 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 | Biotech Hunter | Biotech Hunter