OncoMatch/Clinical Trials/NCT07059975
UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML
Is NCT07059975 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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 mutation
Mutated NPM1
Required: CEBPA bzip mutation
CEBPA bZIP mutation
Required: RBM15 rbm15(ott) fusion
t(1;22)(p13.3;q13.1) RBM15(OTT) fusion
Required: MNX1 mnx1-etv6 fusion
t(7;12)(q36.3;p13.2) MNX1::ETV6
Required: KAT6A kat6a-crebbp fusion
t(8;16)(p11.2;p13.3) KAT6A::CREBBP
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
Required: KMT2A (MLL) partial tandem duplication
11q23.3 partial tandem duplication (PTD) KMT2A PTD
Excluded: FLT3 itd
AML with FLT3 internal tandem duplication (FLT3-ITD) allelic ratio >0.1
Demographics
Prior therapy
Must have received: cytarabine + daunorubicin + gemtuzumab ozogamicin (DA10+GO) induction (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
Kidney function
estimated 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 for this study)
Cardiac function
Ejection fraction (EF) ≥ 50% (preferred) or shortening fraction (SF) ≥ 24% within 14 days prior to Induction 2; repeat echo if EF < 50% or SF <24% and clinical stabilization
Adequate renal function defined as: estimated 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 (ULN=45 U/L for this study). Adequate coagulation: INR ≤ 1.5. Adequate cardiac function: EF ≥ 50% or SF ≥ 24% within 14 days prior to Induction 2.
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 →Frequently asked questions
Is NCT07059975 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cytarabine + daunorubicin + gemtuzumab ozogamicin (DA10+GO) induction.
Does this trial require RUNX1?
Yes, RUNX1 runx1-runx1t1 fusion is a required biomarker for enrollment.
Does this trial require CBFB?
Yes, CBFB cbfb-myh11 fusion is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Are patients with FLT3 alterations eligible?
No. FLT3 itd is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 30 years or younger and at least 0 years old.
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