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OncoMatch/Clinical Trials/NCT05260528

CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics

Is NCT05260528 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cytarabine and Idarubicin and CPX-315 for acute myeloid leukemia.

Phase 2RecruitingCentre Hospitalier Universitaire de NiceNCT05260528Data as of May 2026

Treatment: Cytarabine and Idarubicin · CPX-315The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: FLT3 wild-type

Required: NPM1 wild-type

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Exception: short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms

Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms

Cannot have received: radiation therapy

Exception: local radiotherapy for prostate cancer

Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer)

Lab requirements

Blood counts

as indicated detailed with laboratory values in the section IV of the protocol

Kidney function

as indicated detailed with laboratory values in the section IV of the protocol

Liver function

as indicated detailed with laboratory values in the section IV of the protocol

Cardiac function

Cardiac ejection fraction <50% or considered as abnormal by echocardiography or MUGA scan [excluded]

Patient must have adequate organ function as indicated detailed with laboratory values in the section IV of the protocol; Cardiac ejection fraction <50% or considered as abnormal by echocardiography or multi-gated acquisition (MUGA) scan [excluded]

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

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