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Acute Myeloid LeukemiaEarly Phase 1NCT07059975

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

A Early Phase 1 study testing Idarubicin Hydrochloride, Fludarabine and Cytarabine (Ara-C) in people with Acute Myeloid Leukemia and Pediatric AML, run by Baylor College of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This research study investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients with newly diagnosed AML at intermediate-risk (IR) and high-risk (HR) of relapse. Read more about this study

Who is it for?
Ages 1 month to 30 years
Conditions the study is for
Acute Myeloid Leukemia, Pediatric AML
What is being tested?
Idarubicin Hydrochloride, Fludarabine and Cytarabine (Ara-C)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
22 Oct 2025to Aug 2031
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age Patients ≥ 1 months old to ≤ 30 years old are eligible
  • Patients must be diagnosed with AML or myeloid sarcoma according to the 2022 WHO classification with or without extramedullary disease. Patients with AML must have 1 of the following at initial diagnosis:
  • Diagnosis
  • ≥ 20% bone marrow blasts
  • In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy.
  • < 20% bone marrow blasts with one or more of the genetic abnormalities below:
Show all 37Show fewer
  • 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
  • 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).
  • Biopsy-proven myeloid sarcoma with or without bone marrow involvement.
  • Note: patients with newly diagnosed AML, myelodysplasia-related (that are not from conditions listed in protocol section 4.2.1) ARE eligible while patients with therapy-related AML are excluded.
  • Prior Therapy Patients must receive DA10+GO (Cytarabine days 1-10 + Daunorubicin days 1,3,5 [DA10] + Gemtuzumab ozogamcin [GO]) as prescribed in AAML1831 or the TXCH practice standard for Induction 1. Patients may have received any number of intrathecal treatments and have any CNS status at the time of enrollment.
  • 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.
  • Adequate renal function defined as:
  • An estimated creatinine clearance or GFR ≥ 60 ml/min/1.73m2. Any calculation method is acceptable, including the automatic creatinine clearance provided within the Epic EMR.
  • Adequate liver function defined as:
  • 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.
  • Adequate coagulation defined as:
  • INR ≤ 1.5
  • Adequate cardiac function defined as:
  • 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.

Who cannot join

  • Patients with the following constitutional conditions are not eligible:
  • Fanconi anemia
  • Schwachman Diamond Syndrome
  • Telomere Disorders
  • 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
Show all 17Show fewer
  • Therapy-related AML
  • Patients with any of the following oncologic diagnoses are not eligible:
  • Any concurrent malignancy
  • Juvenile myelomonocytic leukemia
  • Philadelphia chromosome positive AML
  • Mixed phenotype acute leukemia
  • Acute promyelocytic leukemia
  • AML with FLT3 internal tandem duplication (FLT3-ITD) allelic ratio >0.1
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joanna S Yi, MD contact

832-824-6699

jsyi@texaschildrens.org

Alexandra M Stevens, MD, PhD contact

832-824-4824

amsteven@texaschildrens.org

United States1 site, 1 recruiting

  • Texas Children's Cancer and Hematology Center

    Houston, Texas, 77030

    Joanna S Yi, MD, 832-824-6699, jsyi@texaschildrens.org

    Alexandra M Stevens, MD, PhD, 832-824-4824, amsteven@texaschildrens.org

    Recruiting

Other trials in United States

About this study

Official title: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML: A Pilot Trial

This research study investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients with newly diagnosed AML at intermediate-risk (IR) and high-risk (HR) of relapse. The goal is to achieve similar or better survival with chemotherapy cycles that are intensive but less likely to cause long-term complications. Patients will enroll on this trial at the end of their first induction cycle.

The two cycles to be substituted are:

Read more
  • "Ida-FLA" (idarubicin+fludarabine/cytarabine) as Induction 2
  • "VIA" (venetoclax+idarubicin+cytarabine) as Intensification 1 of the HR treatment regimen, and Intensification 2 of the IR treatment backbone.

Researchers will evaluate side effects and outcomes for up to three years after enrollment.

Participants will also have the opportunity to participate in optional research studies including patient surveys and blood and bone marrow sample testing.

Read the detailed description

UPDATE AML is a research study that investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients at intermediate-risk (IR) and high-risk (HR) of the leukemia coming back ("relapse"). Newly diagnosed patients will receive standard Induction 1 treatment off study. If they do not have a FLT3-ITD mutation, they will be eligible to complete treatment on the UPDATE AML study. Patients considered Low Risk will receive the standard treatments outside of the UPDATE AML trial but will be eligible for the non-treatment parts of the trial. IR and HR patients will receive a combination of idarubicin, fludarabine, cytarabine (Ida-FLA) as their 2nd cycle of chemotherapy ("Induction 2"). This combination has shown desirable anti-leukemic activity in children whose leukemia has relapsed but has not yet been studied extensively in children newly diagnosed with AML. Secondly the trial will administer the new drug venetoclax (FDA approved for adults with AML but not for pediatric patients) combined with idarubicin and cytarabine as the 3rd or 4th cycle (of the HR or IR regimens respectively). Texas Children's Hospital will be providing the venetoclax.

The other major goal of UPDATE AML is to improve to detection of residual leukemia. Currently, the intensity of treatment for pediatric patients with AML depends on the genetic changes in the leukemia cells and their response to the first month of therapy. Of patients who have no detectable residual disease at the end of the first month, 30% of them will still relapse, indicating residual leukemia was still present, just not detected. Our study will develop individualized tests for each patient's genetic change which should increase detection of tiny amounts of residual leukemia. If our trial can successfully develop these individualized tests, future pediatric AML trials will incorporate these tests into use for all patients.

The research study procedures include screening for eligibility study treatment, evaluation, administration of the substituted chemotherapy cycles, and follow-up visits. Participants will be offered the possibility to provide additional blood and bone marrow samples (to be collected only at times of regular medical examination). There are additional surveys patients and parents can participate in, to understand the challenges facing families undergoing pediatric AML treatment.

Besides the 2 substituted chemotherapy cycles, patients will otherwise receive standard chemotherapy as their relapse risk indicates. Patients will be followed for approximately 3 years from enrollment.

It is expected that about 36 people will take part in this research study.

Being tested
Idarubicin Hydrochloride, Fludarabine, Cytarabine (Ara-C), Venetoclax, Etoposide
Keywords
venetoclax, measurable residual disease (MRD), digital PCR
Medical subject headings
Leukemia, Myeloid, Acute, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Idarubicin HydrochlorideDrug

    Idarubicin is given in combination with fludarabine and cytarabine for Ida-FLA, and in combination with venetoclax and cytarabine for VIA.

  • FludarabineDrug

    Fludarabine is given in combination with idarubicin and cytarabine for Ida-FLA.

  • Cytarabine (Ara-C)Drug

    Cytarabine is given in combination with other chemotherapy agents in every cycle and both arms.

  • VenetoclaxDrug

    Venetoclax is given in combination with idarubicin and cytarabine for VIA.

  • EtoposideDrug

    Etoposide is given in combination with cytarabine for AE, as Intensification 1 for IR patients.

  • Asparaginase Erwinia Chrysanthemi (recombinant)Drug

    Rylaze is given in combination with cytarabine for Intensification 3 for IR patients.

  • Intrathecal tripleDrug

    Methotrexate, hydrocortisone and cytarabine are combined into one preparation for intrathecal administration at multiple time points during treatment.

  • SOCOther

    Low-Risk Patients will receive Texas childern's Hospital practice standard for de novo AML.

Study groups in NCT07059975
Study groupRoleWhat they receive
Intermediate Risk (IR) AMLExperimentalPatients will receive Ida-FLA as Induction 2, cytarabine/etoposide ("AE") as Intensification 1, VIA as Intensification 2, and Capizzi AraC as intensification 3.
Receives: Drug: Idarubicin Hydrochloride; Drug: Fludarabine; Drug: Cytarabine (Ara-C); Drug: Venetoclax; Drug: Etoposide; Drug: Asparaginase Erwinia Chrysanthemi (recombinant); Drug: Intrathecal triple
High risk (HR) AMLExperimentalPatients will receive Ida-FLA as Induction 2 and VIA as Intensification 1. These patients will then proceed on to a hematopoietic stem cell transplantation if an appropriate donor is found, otherwise will receive 2 more cycles of chemotherapy following the IR regimen.
Receives: Drug: Idarubicin Hydrochloride; Drug: Fludarabine; Drug: Cytarabine (Ara-C); Drug: Venetoclax; Drug: Intrathecal triple
Low risk (LR)OtherLow risk pediatric AML patients will receive standard of care chemotherapy but have the option to participate in correlative studies
Receives: Other: SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability rate 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.

    Measured: From Day 1 of Ida-FLA through up to 50 days after completion of Ida-FLA

  2. Tolerability rate of VIA for IR patients

    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.

    Measured: From Day 1 of VIA through up to 50 days after completion of VIA

  3. Tolerability rate of VIA for HR patients

    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.

    Measured: From Day 1 of VIA through up to 50 days after completion of VIA

Secondary outcomes (7)

  1. Complete remission rate

    Complete remission (CR/CRi/CRp) will be defined asbone marrow blast <5% by morphology with regenerating normal hematopoietic cells, negative CSF cytology, and no extramedullary disease. Number of complete remission respondents.The complete remission rate will be estimated as the proportion of the Induction 2 population that is in complete remission at the end of Induction 2 for IR and HR patients A cycle of Ida-FLA(induction 2) is 29-36 days.

    Measured: at the end of Induction 2 which may occur between day 29 and day 36 of the cycle

  2. MRD negative rate

    The MRD assessment will be based on the subset of the Induction 2 in IR + HR population that were MRD positive at the end of Induction 1.The MRD negative rate will be estimated as the proportion of IR+HR patients who are MRD negative (<0.05% by flow cytometry) at the end of Induction 2, out of the number of IR+HR patients who were MRD positive (>0.05% by flow cytometry) at the end of Induction 1.

    A cycle of Ida-FLA(induction 2) is 29-36 days.

    Measured: at the end of Induction 2 which may occur between day 29 and day 36 of the cycle

  3. 3 year event-free survival

    Event-free survival (EFS) is defined as the time from study enrollment until refractory disease or relapse, death due to any cause or last date of follow-up over 3 years in IR and HR, separately. The median survival time will be estimated using the Kaplan-Meier method.

    Measured: from enrollment up to 3 years

  4. 3 year overall survival

    Overall survival (OS) is defined as time from study entry until death due to any cause or last date of follow-up over 3 years in IR and HR, separately.The median survival time will be estimated using the Kaplan-Meier method.

    Measured: From enrollment up to 3 years

  5. Rate of count recovery in IR Intensification 1

    The time to post-nadir recovery of absolute neutrophil count (ANC) to >500/μL and platelets to >20,000/μL (without transfusion) is determined for IR patients at the end of Intensification 1. Count recovery is defined above. Day 42 is a standard benchmark for count recovery, beyond which recovery is considered delayed. The proportion of IR patients who achieve full count recovery by day 42 of Intensification 1 will be estimated using the Kaplan-Meier method.

    A cycle of intensification 1 is 29-36 days.

    Measured: at the end of Intensification 1 which may occur between day 29 and day 36 of the cycle

  6. Tolerability rate of intensified regimen as a whole for IR patients

    Tolerability of the IR regimen overall is assessed at the end of Intensification 3 for IR patients.

    The overall tolerability rate for IR patients receiving the intensified IR regimen as a whole will be calculated as the proportion of IR patients who complete of protocol therapy without severe toxicity requiring removal from the regimen, as defined in Section 6.6 of the protocol as follow:

    Non-Hematological Toxicity: Any Grade 5 toxicity, Grade 4 cardiac disorder, 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 intensification 3 is 29-36 days.

    Measured: at the end of Intensification 3 which may occur between day 29 and day 36 of the cycle

  7. Tolerability rate of intensified regimen as a whole for HR patients

    Tolerability of the HR regimen overall is assessed at day +30 after HSCT for HR patients.

    The overall tolerability rate for HR patients receiving the intensified HR regimen as a whole will be calculated as the proportion of HR patients who complete of protocol therapy and HSCT without severe toxicity requiring removal from the regimen, as defined in Section 6.6 of the protocol as follow:

    Non-Hematological Toxicity: Any Grade 5 toxicity, Grade 4 cardiac disorder, 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 is 29-36 days.

    Measured: at day 30 after completion of HSCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start22 Oct 2025
  3. Primary completionOct 2028 (estimated)
  4. Study completionAug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Pilot study with assigned risk-based treatment arms, all receiving the study interventions
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07059975
Sponsor's protocol ID
H-56184 UPDATE AML
Status last verified
Nov 2025
First submitted
18 Jun 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: All of the planned analyses, including the correlative biology, will be done by members of the study committee.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Idarubicin Hydrochloride, Fludarabine and Cytarabine (Ara-C) in people with Acute Myeloid Leukemia and Pediatric AML, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joanna S Yi, MD (832-824-6699, jsyi@texaschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability rate of Ida-FLA (time frame: From Day 1 of Ida-FLA through up to 50 days after completion of Ida-FLA). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07059975.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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