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