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    DRUG:

    idarubicin hydrochloride

    i
    Other names: IDA, DMDR, FCE 22723, IMI 30, NSC 256439
    Company:
    Generic mfg.
    Drug class:
    Topoisomerase II inhibitor, DNA cross linking agent
    Related drugs:
    1d
    VAG-3+7-G: VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China | Initiation date: Jan 2026 --> Apr 2026
    Trial initiation date
    |
    FLT3 (Fms-related tyrosine kinase 3) • BCL2 (B-cell CLL/lymphoma 2)
    |
    FLT3-ITD mutation • FLT3-TKD mutation
    |
    Venclexta (venetoclax) • cytarabine • Xospata (gilteritinib) • azacitidine • daunorubicin • idarubicin hydrochloride
    6d
    Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML (clinicaltrials.gov)
    P3, N=204, Not yet recruiting, The First Affiliated Hospital of Soochow University
    New P3 trial
    |
    Venclexta (venetoclax) • azacitidine • idarubicin hydrochloride • Duoenda (mitoxantrone liposomal)
    9d
    The Relationship between OPN, NLR and Chemotherapy Efficacy in Patients with Acute Myeloid Leukemia (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi)
    The combination of Ara-C and IDA in AML patients has a risk of ineffective induction chemotherapy, which may be related to serum OPN and NLR values. High expression of serum OPN and elevated NLR value may increase the risk of ineffective induction chemotherapy. The combination of serum OPN and NLR can assist in improving the predictive value of Ara-C combined with IDA in AML patients.
    Retrospective data • Journal
    |
    B2M (Beta-2-microglobulin) • SPP1 (Secreted Phosphoprotein 1)
    |
    cytarabine • idarubicin hydrochloride
    11d
    A phase I/II study of gilteritinib in combination with chemotherapy in newly diagnosed patients with AML in Asia: final analysis. (PubMed, Ther Adv Hematol)
    All patients enrolled in phase II received induction and consolidation therapy with gilteritinib 120 mg/day plus chemotherapy (induction: ⩽2 cycles, idarubicin/cytarabine once-daily; consolidation: ⩽4 cycles, cytarabine twice-daily) followed by maintenance with gilteritinib 120 mg/day monotherapy (⩽26 cycles). Induction and consolidation with gilteritinib plus chemotherapy, and maintenance with gilteritinib monotherapy were well tolerated in ND patients in Asia with FLT3 mut+ AML and had favorable efficacy compared with historical data. This trial was registered with the ClinicalTrials.gov identifier NCT02310321.
    P1/2 data • Journal
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride
    13d
    A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2029 --> May 2029 | Trial primary completion date: May 2027 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    cytarabine • etoposide IV • midostaurin • daunorubicin • idarubicin hydrochloride • mitoxantrone • fludarabine IV
    16d
    RESOLVE trial: Registry and clinical trial comparing standard intensity and reduced intensity treatment in patients with AML or CLL who do not have residual disease. (2024-512503-39-00)
    P4, N=289, Recruiting, Medizinische Hochschule Hannover | N=128 --> 289
    Enrollment change • Minimal residual disease
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • cytarabine • Gazyva (obinutuzumab) • cyclophosphamide • etoposide IV • midostaurin • Vanflyta (quizartinib) • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • idarubicin hydrochloride • mitoxantrone • cladribine • fludarabine IV • thiotepa • busulfan • Grafapex (treosulfan)
    19d
    RESOLVE trial: Registry and clinical trial comparing standard intensity and reduced intensity treatment in patients with AML or CLL who do not have residual disease. (2024-512503-39-00)
    P4, N=128, Recruiting, Medizinische Hochschule Hannover | N=52 --> 128
    Enrollment change • Minimal residual disease
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • cytarabine • Gazyva (obinutuzumab) • cyclophosphamide • etoposide IV • midostaurin • Vanflyta (quizartinib) • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • idarubicin hydrochloride • mitoxantrone • cladribine • fludarabine IV • thiotepa • busulfan • Grafapex (treosulfan)
    22d
    NCI-2019-08626: BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=49, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2026 --> Jan 2027
    Trial completion date • Tumor mutational burden
    |
    Keytruda (pembrolizumab) • cytarabine • daunorubicin • idarubicin hydrochloride • Starasid (cytarabine ocfosfate)
    1m
    NCI-2023-03572: Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms (clinicaltrials.gov)
    P1, N=30, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Dec 2027 --> Dec 2029
    Trial completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    Chr t(15;17)
    |
    cytarabine • idarubicin hydrochloride • fludarabine IV • pivekimab sunirine (PVEK) • Starasid (cytarabine ocfosfate)
    1m
    Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia (clinicaltrials.gov)
    P3, N=158, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2025 --> Jun 2029
    Trial completion date
    |
    RARA (Retinoic Acid Receptor Alpha) • PML (Promyelocytic Leukemia)
    |
    cytarabine • idarubicin hydrochloride • mitoxantrone • Vesanoid (tretinoin) • arsenic trioxide • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    1m
    IntReALL BCP 2020 International Study for Treatment of Childhood Relapsed Precursor B-cell ALL 2020 (2023-509392-17-00)
    P2/3, N=765, Not yet recruiting, Charite Universitaetsmedizin Berlin KR
    New P2/3 trial
    |
    CD22 (CD22 Molecule)
    |
    CD19 positive • CD22 positive
    |
    cytarabine • Blincyto (blinatumomab) • etoposide IV • Besponsa (inotuzumab ozogamicin) • vincristine • idarubicin hydrochloride • mitoxantrone • mercaptopurine • vindesine
    1m
    SNDX-5613-0710: Phase 3 Study of Revumenib in Combination with Intensive Chemotherapy in Newly Diagnosed NPM1-mutated AML (2025-522279-27-00)
    P2/3, N=239, Not yet recruiting, Syndax Pharmaceuticals Inc.
    New P2/3 trial
    |
    NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
    |
    cytarabine • daunorubicin • Revuforj (revumenib) • idarubicin hydrochloride