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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

Researching the best dose of Imetelstat with other drugs for certain blood cancers.

Recruiting
1-18 years
All
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study aims to find the best dose of a new drug, imetelstat, combined with two other drugs, fludarabine and cytarabine, for treating certain blood cancers in young patients. These cancers include acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and juvenile myelomonocytic leukemia (JMML). Imetelstat works by stopping cancer cells from growing. The other two drugs are chemotherapy medicines that kill cancer cells or stop them from spreading. The study will check how safe these drugs are together and what side effects they might cause. It will also see how well this drug combination works to help patients. Participants will receive these drugs through a vein over a few days, with treatment cycles repeating every 28 days for up to two cycles. After treatment, patients will be monitored for five years.

  • **Length of Study**: Participants will be treated for up to two cycles, each lasting 28 days.
  • **Visits Needed**: Regular hospital visits are required for treatment and follow-up checks.
  • **Eligibility**: Patients aged 1-18 years with AML, MDS, or JMML that hasn't responded well to previous treatments.
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Study details
    Recurrent Childhood Acute Myeloid Leukemia
    Recurrent Childhood Myelodysplastic Syndrome
    Recurrent Juvenile Myelomonocytic Leukemia
    Refractory Childhood Acute Myeloid Leukemia
    Refractory Childhood Myelodysplastic Syndrome
    Refractory Juvenile Myelomonocytic Leukemia

NCT06247787

Children's Oncology Group

7 March 2026

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