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UPDATE AML: Improving Outcomes for Pediatric Acute Myeloid Leukemia

This study, called UPDATE AML, is for children and young adults (ages 1 month to 30 years) newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer. It's testing if replacing two cycles of standard chemotherapy with different drug combinations can lead to similar or better results with fewer long-term side effects. The study will look at how well patients tolerate these new combinations: "Ida-FLA" (idarubicin, fludarabine, and cytarabine) and "VIA" (venetoclax, idarubicin, and cytarabine). You would join the study after your first round of chemotherapy. The main goal is to see how well patients tolerate these new treatments, measured up to 50 days after each new cycle.

Study design
This is an interventional study planning to enroll 36 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Tolerability will be measured up to 50 days after completing each new chemotherapy cycle.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07059975

UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML

Recruiting
EARLY_PHASE1Ages 1–30InterventionalTreatment
Baylor College of Medicine
~36 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Idarubicin HydrochlorideFludarabineCytarabine (Ara-C)VenetoclaxEtoposideAsparaginase Erwinia Chrysanthemi (recombinant)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tolerability rate of Ida-FLA
Measured over From Day 1 of Ida-FLA through up to 50 days after completion of Ida-FLA
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
Pediatric AML

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Acute Myeloid LeukemiaMyeloid SarcomaCBFB GeneKMT2A GeneMECOM GeneNPM1 GeneNUP98 GeneProtein CBFA2T3Protein DEKRNA-Binding Protein 15RUNX1 Gene

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Joanna S Yi, MD
[email protected]
832-824-6699
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age Patients ≥ 1 months old to ≤ 30 years old are eligible
t(8;21)(q22;q22.1) RUNX1::RUNX1T1
inv(16)(p13.1q22) or t(16;16)(p13.1;q22) CBFB::MYH11
Translocation involving 11q23.3 KMT2A rearrangement
t(6;9)(p23;q34.1) DEK::NUP214
inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2) MECOM rearrangement
Megakaryoblastic with t(1;22)(p13.3;q13.3) RBM15::MRTFA
Mutated NPM1
CEBPA bZIP mutation
t(1;22)(p13.3;q13.1) RBM15(OTT) fusion
t(7;12)(q36.3;p13.2) MNX1::ETV6
t(8;16)(p11.2;p13.3) KAT6A::CREBBP - t(5;11)(q35.3;p15.5) NUP98::NSD1
inv(16)(p13.3q24.3) CBFA2T3::GLIS2
t(11;12)(p15.5;p13.5) NUP98::KDM5A
11q23.3 partial tandem duplication (PTD) KMT2A PTD 3. A complete blood count (CBC) documenting the presence of at least 1,000/µL circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (i.e., a WBC count ≥ 10,000/μL with ≥ 10% blasts or a WBC count of ≥ 5,000/μL with ≥ 20% blasts). 4. Biopsy-proven myeloid sarcoma with or without bone marrow involvement.
Performance Status Patients must have a performance status corresponding to Karnofsky/Lansky score \>/=40. (Use Karnofsky for patients ≥16 years of age and Lanksy for patients \<16 years of age.)
Organ Function Requirements All laboratory studies to determine eligibility must be performed within seven (7) days prior to enrollment unless otherwise indicated. Laboratory values used to assess eligibility must be no older than 7 days at the start of Induction 2 therapy and need not be repeated if therapy starts within 7 days of the eligibility labs. If a post-enrollment lab value is outside the limits of eligibility, or laboratory values are \>7 days old, then the following laboratory evaluations must be re-checked within 48 hours prior to initiating therapy: bilirubin, ALT (SGPT) and serum creatinine. If the recheck is outside the limits of eligibility, the patient should be followed with periodic labs but may not receive protocol therapy until the bilirubin, ALT, and/or serum creatinine meet eligibility criteria. If \>14 days have passed from the planned start of protocol therapy and the bilirubin, ALT, and/or serum creatinine are still outside the limits of eligibility, the patient may not receive protocol therapy and rather will be considered a screen failure.
A direct bilirubin \< 2 mg/dL
ALT \<5x ULN or 225 U/L, with the ULN being 45 U/L for the purpose of this study.
Ejection fraction (EF) ≥ 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) ≥ 24%, within 14 days prior to planned start of Induction 2 therapy.
For patients with cardiac dysfunction (EF \< 50% or SF \<24% if EF is unavailable) prior to enrollment, if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF ≥ 50%, the patient is eligible to enroll.
Informed Consent All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion

Patients with the following constitutional conditions are not eligible:
Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
Germline predispositions known, or suspected by the treating physician, to increase risk of toxicity with AML therapy
Therapy-related AML
Patients with any of the following oncologic diagnoses are not eligible:
Pregnancy and Breastfeeding • Female patients who are pregnant may not participate. A pregnancy test is required for female patients of childbearing potential.
Lactating females who plan to breastfeed their infants are not eligible.
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are not eligible.

What this trial measures

  • Tolerability rate of Ida-FLAFrom Day 1 of Ida-FLA through up to 50 days after completion of Ida-FLA

    Tolerability rate is the proportion of participants in the tolerability dataset who did not experience an intolerable event during Induction 2 for IR and HR patients. Number of intolerable participants will be used. Intolerability is defined by events outlined in Section 6.6 of the protocol as follow: Non-Hematological Toxicity: Any Grade 5 toxicity, Grade 4 left ventricular systolic dysfunction or QTc prolongation, Grade 4 infection or sepsis, or other Grade 4+ non-hematologic toxicity except: * Grade 4 nausea/vomiting (\<3 days) * Grade 4 ALT/AST/GGT elevation (returns to ≤Grade 1 before next cycle) * Grade 4 electrolyte abnormalities (corrected by supplementation) * Cycle delays \>50 days indicate intolerability. Hematologic Toxicity: Intolerability includes failure to recover ANC \>500/mL and platelets \>20,000/mL (without transfusion in past 7 days) by day 50 or cycle start delay \>50 days. A cycle of Ida-FLA is 29-36 days.

  • Tolerability rate of VIA for IR patientsFrom Day 1 of VIA through up to 50 days after completion of VIA

    Tolerability rate is the proportion of participants in the tolerability dataset who did not experience an intolerable event during intensification 2 for IR patients as the 4th cycle. Number of intolerable participants will be used. Intolerability is defined by events outlined in Section 6.6 of the protocol as follow: Non-Hematological Toxicity: Any Grade 5 toxicity, Grade 4 left ventricular systolic dysfunction or QTc prolongation, Grade 4 infection, or other Grade 4+ non-hematologic toxicity except: * Grade 4 nausea/vomiting (\<3 days) * Grade 4 ALT/AST/GGT elevation (returns to ≤Grade 1 before next cycle) * Grade 4 electrolyte abnormalities (corrected by supplementation) * Cycle delays \>50 days indicate intolerability. Hematologic Toxicity: Intolerability includes failure to recover ANC \>500/mL and platelets \>20,000/mL (without transfusion in past 7 days) by day 50 or cycle start delay \>50 days. A cycle of VIA is 29-36 days.

  • Tolerability rate of VIA for HR patientsFrom Day 1 of VIA through up to 50 days after completion of VIA

    Tolerability rate is the proportion of participants in the tolerability dataset who did not experience an intolerable event during intensification 2 for HR patients as the 3rd cycle. Number of intolerable participants will be used. Intolerability is defined by events outlined in Section 6.6 of the protocol as follow: Non-Hematological Toxicity: Any Grade 5 toxicity, Grade 4 left ventricular systolic dysfunction or QTc prolongation, Grade 4 infection, or other Grade 4+ non-hematologic toxicity except: * Grade 4 nausea/vomiting (\<3 days) * Grade 4 ALT/AST/GGT elevation (returns to ≤Grade 1 before next cycle) * Grade 4 electrolyte abnormalities (corrected by supplementation) * Cycle delays \>50 days indicate intolerability. Hematologic Toxicity: Intolerability includes failure to recover ANC \>500/mL and platelets \>20,000/mL (without transfusion in past 7 days) by day 50 or cycle start delay \>50 days. A cycle of VIA is 29-36 days.