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    DRUG:

    Duoenda (mitoxantrone liposomal)

    i
    Other names: PLM60, 2010L04017, HE071
    Associations

    News

    Trials
    Company:
    CSPC Pharma
    Drug class:
    Topoisomerase II inhibitor, DNA intercalator
    Related drugs:
    Associations

    News

    Trials
    20d
    Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML (clinicaltrials.gov)
    P=N/A, N=37, Not yet recruiting, First Affiliated Hospital Xi'an Jiaotong University
    New trial
    |
    fludarabine IV • thiotepa • busulfan • Duoenda (mitoxantrone liposomal)
    1m
    RCT on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P3, N=154, Recruiting, Zhongnan Hospital
    New P3 trial
    |
    azacitidine • daunorubicin • Duoenda (mitoxantrone liposomal)
    2ms
    A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2/Elder AML (clinicaltrials.gov)
    P=N/A, N=78, Recruiting, Ruijin Hospital
    New trial
    |
    Duoenda (mitoxantrone liposomal)
    2ms
    Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia (clinicaltrials.gov)
    P=N/A, N=90, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • cytarabine • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    2ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Advanced Bone and Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=31, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=50 --> 31 | Not yet recruiting --> Terminated; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial termination • Metastases
    |
    Duoenda (mitoxantrone liposomal)
    2ms
    Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL (clinicaltrials.gov)
    P1, N=38, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=63 --> 38 | Recruiting --> Terminated | Trial primary completion date: Mar 2022 --> Jun 2023; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial termination • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    cyclophosphamide • vincristine • prednisone • Duoenda (mitoxantrone liposomal)
    2ms
    A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy (clinicaltrials.gov)
    P2, N=45, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=81 --> 45 | Unknown status --> Terminated; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial termination
    |
    Duoenda (mitoxantrone liposomal)
    2ms
    Clinical Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Pegaspargase in the Treatment of NKTCL (clinicaltrials.gov)
    P1/2, N=41, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=104 --> 41 | Not yet recruiting --> Terminated; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial termination
    |
    Oncaspar liquid (pegaspargase) • Duoenda (mitoxantrone liposomal)
    2ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed Ovarian Cancer (clinicaltrials.gov)
    P1, N=56, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=30 --> 56 | Trial completion date: Jan 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Jan 2022 --> May 2023; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    Duoenda (mitoxantrone liposomal)
    2ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Recurrent/Metastatic Head and Neck Cancers (clinicaltrials.gov)
    P1, N=45, Completed, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Completed | N=30 --> 45 | Trial completion date: Apr 2024 --> Oct 2023 | Trial primary completion date: Apr 2022 --> Oct 2023
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Duoenda (mitoxantrone liposomal)
    2ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma (clinicaltrials.gov)
    P1, N=21, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=30 --> 21 | Recruiting --> Terminated; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial termination • Metastases
    |
    Duoenda (mitoxantrone liposomal)
    3ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=28, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=73 --> 28 | Recruiting --> Terminated; The sponsor has adjusted its R&D strategy.
    Enrollment change • Trial termination • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Duoenda (mitoxantrone liposomal)
    3ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=1, Terminated, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | N=90 --> 1 | Not yet recruiting --> Terminated; Adjust the research strategy.
    Enrollment change • Trial termination
    |
    Duoenda (mitoxantrone liposomal)
    3ms
    A Study of Mitoxantrone Hydrochloride Liposome Injection in Chinese Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=29, Completed, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Completed
    Trial completion
    |
    Duoenda (mitoxantrone liposomal)
    3ms
    Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P2, N=104, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Duoenda (mitoxantrone liposomal)
    3ms
    GMCAII: Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML (clinicaltrials.gov)
    P2, N=500, Recruiting, Children's Hospital of Soochow University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • sorafenib • cytarabine • Xospata (gilteritinib) • etoposide IV • idarubicin hydrochloride • Ayvakit (avapritinib) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    4ms
    GVM±R in Patients With Relapsed or Refractory Aggressive NHL (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • Rituxan (rituximab) • vinorelbine tartrate • Duoenda (mitoxantrone liposomal)
    4ms
    Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Huijing Wu
    New P1/2 trial
    |
    azacitidine • Duoenda (mitoxantrone liposomal)
    4ms
    GMCAII: Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML (clinicaltrials.gov)
    P2, N=500, Not yet recruiting, Children's Hospital of Soochow University
    New P2 trial
    |
    Venclexta (venetoclax) • sorafenib • cytarabine • Xospata (gilteritinib) • etoposide IV • idarubicin hydrochloride • Ayvakit (avapritinib) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    4ms
    Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies (clinicaltrials.gov)
    P2, N=28, Recruiting, Wuhan Union Hospital, China
    New P2 trial
    |
    cytarabine • fludarabine IV • Duoenda (mitoxantrone liposomal)
    4ms
    Chi-GVM Regimen for the Treatment of R/R PTCL (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, The First Affiliated Hospital with Nanjing Medical University
    New trial
    |
    gemcitabine • vinorelbine tartrate • Epidaza (chidamide) • Duoenda (mitoxantrone liposomal)
    5ms
    VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P2, N=66, Recruiting, The First Affiliated Hospital of Xiamen University | Not yet recruiting --> Recruiting | Trial completion date: Jun 2025 --> Dec 2026
    Enrollment open • Trial completion date
    |
    Venclexta (venetoclax) • azacitidine • Epidaza (chidamide) • Duoenda (mitoxantrone liposomal)
    5ms
    Mitoxantrone liposome combined with etoposide, cytarabine and cyclophosphamide (PLMEAC) in the treatment of NK/T cell lymphoma and T lymphoblastic lymphoma: A single-arm, multicenter study (ChiCTR2300072614)
    P=N/A, N=24, Not yet recruiting, Xinqiao Hospital Army Medical University; Xinqiao Hospital Army Medical University
    New trial
    |
    CD34 (CD34 molecule)
    |
    cyclophosphamide • etoposide IV • Duoenda (mitoxantrone liposomal)
    5ms
    Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer (clinicaltrials.gov)
    P=N/A, N=24, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New trial
    |
    capecitabine • Duoenda (mitoxantrone liposomal)
    6ms
    Mitoxantrone Hydrochloride Liposome, Gemcitabine, Vinorelbine with or without Rituximab (GVM±R) in Patients with Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma (ASH 2023)
    The GVM±R regimen exhibited manageable safety and encouraging efficacy in patients with r/r aNHL, despite the fact that the majority of these patients had received anthracycline-containing chemotherapy in their previous treatment. The trial is still ongoing to determine the recommended phase 2 dose for the subsequent phase 2 clinical study.
    Clinical
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    gemcitabine • Rituxan (rituximab) • vinorelbine tartrate • Duoenda (mitoxantrone liposomal)
    7ms
    Combination of Liposomal Mitoxantrone, Venetoclax, Homoharringtonine, and Olverembatinib (HQP1351) (MVHO) in Pediatric Patients with Refractory or Relapsed Acute Myeloid Leukemia (AML): Case Series (ASH 2023)
    Prophylactic oral levofloxacin and posaconazole were administered from day 8 through whole myelosuppression period of every cycles. MVHO therapy was effective and reasonably well tolerated in pediatric patients with refractory or relapsed AML, suggesting that it may comprise a suitable first-line treatment option for pediatric AML patients.
    Clinical
    |
    NUP98 (Nucleoporin 98 And 96 Precursor 2) • FUS (FUS RNA Binding Protein) • CBFA2T3 (CBFA2/RUNX1 Partner Transcriptional Co-Repressor 3) • GLIS2 (GLIS Family Zinc Finger 2)
    |
    NUP98 rearrangement
    |
    Venclexta (venetoclax) • Nailike (olverembatinib) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    10ms
    Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia (clinicaltrials.gov)
    P=N/A, N=90, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital
    New trial
    |
    Venclexta (venetoclax) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    11ms
    Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia (clinicaltrials.gov)
    P=N/A, N=90, Not yet recruiting, CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
    New trial
    |
    Venclexta (venetoclax) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    12ms
    Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov)
    P2, N=104, Not yet recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    New P2 trial
    |
    Duoenda (mitoxantrone liposomal)
    1year
    Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=20, Recruiting, Second Affiliated Hospital of Soochow University
    New P1/2 trial
    |
    Darzalex (daratumumab) • Duoenda (mitoxantrone liposomal)
    1year
    IN VITRO CHEMOSENSITIVITY ASSAY PREDICTS TREATMENT RESPONSE IN RELAPSED AND REFRACTORY ACUTE MYELOID LEUKEMIA (EHA 2023)
    Leukemia cells from bone marrow of patients were collected, isolated and cultured for drug sensitivity screening (drug regimens included Mitoxantrone liposome, Venetoclax, Azacitidine, Selinexor, Homoharringtonine, Gilteritinib Cytarabine and Cyclophosphamide). In R/R AML patients, individualized regimen based on drug sensitivity assay shows high efficacy and safety, especially in the combination regimens containing mitoxantrone liposome. Acute myeloid leukemia, relapsed/refractory
    Preclinical
    |
    Venclexta (venetoclax) • cytarabine • Xospata (gilteritinib) • azacitidine • cyclophosphamide • Xpovio (selinexor) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal)
    over1year
    Combination of Mitoxantrone Hydrochloride Liposome with Cyclophosphamide, Vincristine and Prednisone (CMOP) in Treatment-Naïve Patients with Peripheral T-Cell Lymphoma: A Multicenter, Open-Label, Single-Arm, Phase Ib Clinical Trial (ASH 2022)
    Front-line treatment with brentuximab vedotin plus CHP only provided moderate improvement in CD30-positive PTCL. At the cut-off data of June 23, 2022, 31 patients were screened in the 6 institutions in China, of which 26 eligible patients (19 males) with a median age of 51.5 (range, 28-70) were enrolled in phase Ib study. Enrolled patients included the following PTCL subtypes: AITL (53.8%), PTCL-NOS (15.4%), ALCL-ALK+ (7.7%), ALCL-ALK- (7.7%) and other subtypes (15.4%). 10 patients (38.5%) presented with B symptom and 20 patients (76.9%) were at the stage III or IV.
    Clinical • P1 data
    |
    ALK (Anaplastic lymphoma kinase) • TNFRSF8 (TNF Receptor Superfamily Member 8)
    |
    TNFRSF8 positive
    |
    cyclophosphamide • Adcetris (brentuximab vedotin) • vincristine • Duoenda (mitoxantrone liposomal)
    almost3years
    Liposomal Mitoxantrone Hydrochloride Injection,Cyclophosphamide, Vincristine and Prednisone in the Treatment of PTCL (clinicaltrials.gov)
    P1, N=63, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    vincristine • Duoenda (mitoxantrone liposomal)
    almost3years
    A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer (clinicaltrials.gov)
    P2, N=73, Recruiting, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Duoenda (mitoxantrone liposomal)