OncoMatch/Clinical Trials/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
Is NCT06247787 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for recurrent childhood acute myeloid leukemia.
Treatment: Cytarabine · Fludarabine · Hydrocortisone Sodium Succinate · Imetelstat · Leucovorin Calcium · Methotrexate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Biomarker criteria
Excluded: BCR fusion
Absence of the t(9;22) or BCR/ABL fusion gene
Excluded: ABL1 fusion
Absence of the t(9;22) or BCR/ABL fusion gene
Excluded: PML fusion
Patients with acute promyelocytic leukemia (APL) with PML-RARA genetic abnormality according to World Health Organization (WHO) classification or t(15;17) are not eligible
Excluded: RARA fusion
Patients with acute promyelocytic leukemia (APL) with PML-RARA genetic abnormality according to World Health Organization (WHO) classification or t(15;17) are not eligible
Allowed: RAS somatic mutation
Somatic mutation in RAS
Allowed: PTPN11 somatic mutation
Somatic mutation in PTPN11
Allowed: NF1 mutation
Clinical diagnosis of NF1 or NF1 gene mutation
Allowed: CBL homozygous mutation
Homozygous mutation in CBL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive frontline therapy or DNA hypomethylating agent (fludarabine, cytarabine, anthracycline) — JMML
Patients with relapsed JMML must have had at least one cycle of intensive frontline therapy or at least 2 cycles of a deoxyribonucleic acid (DNA) hypomethylating agent with persistence of disease
Cannot have received: imetelstat (imetelstat)
Patients must not have received prior exposure to imetelstat
Lab requirements
Blood counts
Platelet count ≥ 25,000/uL (may receive transfusions, not refractory); Hemoglobin ≥ 8.0 g/dL (may receive transfusions)
Kidney function
eGFR ≥ 70 mL/min/1.73 m^2 OR 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m^2
Liver function
Bilirubin ≤ 1.5 x ULN for age; ALT ≤ 3 x ULN unless attributed to leukemia; AST ≤ 3 x ULN unless attributed to leukemia; Albumin ≥ 2 g/dL
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by gated radionuclide study
Platelet count ≥ 25,000/uL (may receive platelet transfusions). Hemoglobin ≥ 8.0 g/dL at baseline (may receive RBC transfusions). Adequate renal function: eGFR ≥ 70 mL/min/1.73 m^2 OR 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m^2. Adequate liver function: Bilirubin ≤ 1.5 x ULN for age; ALT ≤ 3 x ULN unless attributed to leukemia; AST ≤ 3 x ULN unless attributed to leukemia; Albumin ≥ 2 g/dL. Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by gated radionuclide study
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama · Birmingham, Alabama
- Children's Hospital of Orange County · Orange, California
- UCSF Medical Center-Mission Bay · San Francisco, California
- Children's Hospital Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
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