OncoMatch

OncoMatch/Clinical Trials/NCT07059975

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

Is NCT07059975 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments for acute myeloid leukemia.

Early Phase 1RecruitingJoanna YiNCT07059975Data as of May 2026

Treatment: Idarubicin Hydrochloride · Fludarabine · Cytarabine (Ara-C) · Venetoclax · Etoposide · Asparaginase Erwinia Chrysanthemi (recombinant) · Intrathecal tripleThis 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: * "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.

Check if I qualify

Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: RUNX1 RUNX1::RUNX1T1 fusion

t(8;21)(q22;q22.1) RUNX1::RUNX1T1

Required: CBFB CBFB::MYH11 fusion

inv(16)(p13.1q22) or t(16;16)(p13.1;q22) CBFB::MYH11

Required: KMT2A (MLL) rearrangement

Translocation involving 11q23.3 KMT2A rearrangement

Required: DEK DEK::NUP214 fusion

t(6;9)(p23;q34.1) DEK::NUP214

Required: MECOM rearrangement

inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2) MECOM rearrangement

Required: RBM15 RBM15::MRTFA fusion

Megakaryoblastic with t(1;22)(p13.3;q13.3) RBM15::MRTFA

Required: NPM1 mutated

Mutated NPM1

Required: NUP98 NUP98::NSD1 fusion

t(5;11)(q35.3;p15.5) NUP98::NSD1

Required: CBFA2T3 CBFA2T3::GLIS2 fusion

inv(16)(p13.3q24.3) CBFA2T3::GLIS2

Required: NUP98 NUP98::KDM5A fusion

t(11;12)(p15.5;p13.5) NUP98::KDM5A

Excluded: FLT3 internal tandem duplication

AML with FLT3 internal tandem duplication (FLT3-ITD)

Prior therapy

Must have received: cytarabine-based chemotherapy (cytarabine, daunorubicin, gemtuzumab ozogamicin) — Induction 1

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

Lab requirements

Blood counts

CBC with differential required; INR ≤ 1.5

Kidney function

creatinine clearance or GFR ≥ 60 ml/min/1.73m2

Liver function

direct bilirubin < 2 mg/dL; ALT <5x ULN or 225 U/L (ULN=45 U/L)

Cardiac function

Ejection fraction (EF) ≥ 50% or shortening fraction (SF) ≥ 24% within 14 days prior to planned start of Induction 2 therapy

Adequate renal function defined as: creatinine clearance or GFR ≥ 60 ml/min/1.73m2; Adequate liver function defined as: 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: EF ≥ 50% (preferred method Biplane Simpson's EF) or if EF unavailable, SF ≥ 24%, within 14 days prior to planned start of Induction 2 therapy.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Texas Children's Cancer and Hematology Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify