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Anti-metabolites

Imetelstat + Chemotherapy for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Alexandra M Stevens
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be ≥ 1 year and ≤ 18 years of age at the time of study enrollment
Patients with de novo acute myeloid leukemia, therapy-related AML, MDS, or JMML meeting specific relapse criteria
Must not have
Patients receiving corticosteroids not on a stable dose
Patients receiving anti-GVHD agents post-transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from study entry
Awards & highlights

Summary

This trial is testing a new drug called imetelstat in combination with other chemotherapy drugs to see if it is safe and effective in treating patients with certain types of blood cancers that have not responded to

Who is the study for?
This trial is for children and teenagers (1-18 years old) with certain types of leukemia or myelodysplastic syndrome that haven't improved after treatment or have returned. Participants must have specific levels of cancer cells in their bone marrow, confirmed by lab tests.
What is being tested?
The trial is testing the highest safe dose of Imetelstat combined with Fludarabine and Cytarabine in young patients. It aims to find out if this combination can better treat refractory or recurrent acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and juvenile myelomonocytic leukemia (JMML).
What are the potential side effects?
Possible side effects include reactions at the infusion site, increased risk of infection, bleeding problems, nausea, vomiting, fatigue, liver issues, and potential heart damage as monitored by echocardiography.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 and 18 years old.
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I have a specific type of leukemia or myelodysplastic syndrome that has relapsed.
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I am physically active and there is no cure for my condition.
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My blood counts are within the required range and my organs are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My corticosteroid dose is changing.
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I am taking medication to prevent graft-versus-host disease after a transplant.
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I have MDS, uncontrolled seizures, or had recent surgery.
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I am not currently taking any experimental drugs or cancer treatments.
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I am allergic to the study drug or have certain genetic issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from study entry
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from study entry for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities of imetelstat administered in combination with fludarabine and cytarabine
Secondary outcome measures
Antileukemic activity of imetelstat administered in combination with fludarabine and cytarabine
Area under the drug concentration curve of imetelstat administered in combination with fludarabine and cytarabine
Clearance of imetelstat administered in combination with fludarabine and cytarabine
+5 more
Other outcome measures
Cytogenetic abnormalities
Mutational status
Pharmacodynamics
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (Imetelstat, fludarabine, cytarabine)Experimental Treatment11 Interventions
Patients receive imeletstat IV over 2 hours on days 1 and 8, fludarabine IV over 1 hour on days 2-6, and cytarabine IV over 1-3 hours on days 2-6 of each cycle. Patients also receive cytarabine IT or methotrexate IT, and hydrocortisone IT at the provider's discretion. Patients then receive leucovorin calcium IV or PO 24 and 30 hours after each IT triples dose. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, bone marrow biopsy and/or aspirate, blood sample collection, and lumbar puncture for CSF sample collection during screening and on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone Sodium Succinate
2008
Completed Phase 3
~70
Leucovorin Calcium
2011
Completed Phase 3
~12500
Echocardiography
2013
Completed Phase 4
~11580
Cytarabine
2016
Completed Phase 3
~3330
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Fludarabine
2012
Completed Phase 4
~1860
Imetelstat
2012
Completed Phase 2
~100
Lumbar Puncture
2016
Completed Phase 3
~510
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,794 Total Patients Enrolled
Geron CorporationIndustry Sponsor
19 Previous Clinical Trials
1,452 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,964 Total Patients Enrolled
~24 spots leftby Apr 2026
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