Actively Recruiting
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
Led by Children's Oncology Group · Updated on 2026-04-20
36
Participants Needed
19
Research Sites
164 weeks
Total Duration
On this page
Sponsors
C
Children's Oncology Group
Lead Sponsor
G
Geron Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be between 1 and 18 years old at enrollment
- Diagnosis of AML, therapy-related AML, MDS, or JMML with second or greater relapse or refractory disease
- Patients with first or greater relapse of MDS or JMML
- Patients must have relapsed or refractory disease confirmed by appropriate tests
- Patients must have an ECOG performance status of 0, 1, or 2
- Patients must have recovered from prior anti-cancer therapy and meet minimum time intervals since last treatment
- Adequate blood counts and organ function as defined in the study
- No prior exposure to imetelstat
- Recommended flow cytometry and cytogenetic assessments as per protocol
You will not qualify if you...
- Pregnant or breastfeeding females; females and males of reproductive potential not using effective contraception
- Patients receiving unstable corticosteroid doses or immune-modifying corticosteroids within specified timeframes
- Currently receiving other investigational drugs or anti-cancer agents (except hydroxyurea)
- Receiving agents to prevent graft-versus-host disease post-transplant
- Low-grade MDS with less than specified blast counts
- Uncontrolled seizure disorders
- Recent surgery requiring general anesthesia within 3 weeks
- Known hypersensitivity to study drugs
- Patients with acute promyelocytic leukemia with specific genetic abnormalities
- Patients with congenital bone marrow failure syndromes increasing risk of toxicity
- Isolated or refractory CNS or testicular relapse
- Uncontrolled infection
- Prior solid organ transplantation
- Patients unable to comply with study safety monitoring requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
3
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
4
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
7
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
8
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
14
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
15
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
17
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
18
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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