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Duoenda (mitoxantrone liposomal)
i
Other names: PLM60, 2010L04017, HE071
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Company:
CSPC Pharma
Drug class:
Topoisomerase II inhibitor, DNA intercalator
Related drugs:
3d
Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML (clinicaltrials.gov)
P2, N=20, Recruiting, Beijing 302 Hospital
New P2 trial
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azacitidine • decitabine • Duoenda (mitoxantrone liposomal)
1m
A prospective, single-center, single-arm study of mitoxantrone hydrochloride liposome injection combined with venetoclax and azacitidine in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (ChiCTR2400091259)
P4, N=40, Not yet recruiting, General Hospital of Chinese People's Liberation Army Northern Theater Command; General Hospital of Chinese People's Liberation Army Northern Theater C
New P4 trial
|
Venclexta (venetoclax) • azacitidine • Duoenda (mitoxantrone liposomal)
2ms
Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients (clinicaltrials.gov)
P1, N=18, Recruiting, The First Affiliated Hospital of Xiamen University
New P1 trial
|
cytarabine • doxorubicin hydrochloride • decitabine • Duoenda (mitoxantrone liposomal)
3ms
Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML (clinicaltrials.gov)
P2, N=42, Recruiting, First Affiliated Hospital of Zhejiang University
New P2 trial
|
Venclexta (venetoclax) • Duoenda (mitoxantrone liposomal)
3ms
Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML (clinicaltrials.gov)
P=N/A, N=20, Recruiting, First Affiliated Hospital of Zhejiang University
New trial
|
Venclexta (venetoclax) • Duoenda (mitoxantrone liposomal)
3ms
To observe the outcome of mitoxantrone liposome combined with VPD/KPD regimen (bortezomib/Carfilzomib, pomadomide, dexamethasone) in the treatment of multiple myeloma with plasmacytoma: a multicenter real-world clinical study (ChiCTR2400087424)
P4, N=70, Recruiting, Beijing Chaoyang Hospital, Capital Medical University; Beijing Chaoyang Hospital, Capital Medical University
New P4 trial • Real-world evidence • Real-world
|
bortezomib • carfilzomib • dexamethasone • pomalidomide • Duoenda (mitoxantrone liposomal)
3ms
Mitoxantrone Hydrochloride Liposome Combined With Capecitabine in Patients With HER-2 Negative Advanced Breast Cancer (ChiCTR2400088245)
P1, N=48, Recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
New P1 trial • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
capecitabine • Duoenda (mitoxantrone liposomal)
5ms
Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL) (clinicaltrials.gov)
P1, N=16, Recruiting, BGI, China
New P1 trial
|
cyclophosphamide • decitabine • Duoenda (mitoxantrone liposomal)
6ms
Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors (clinicaltrials.gov)
P1, N=68, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2024 --> Sep 2024
Enrollment closed • Trial primary completion date
|
vincristine • Duoenda (mitoxantrone liposomal) • irinotecan liposomal
6ms
Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL (clinicaltrials.gov)
P2, N=89, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
New P2 trial
|
cisplatin • carboplatin • gemcitabine • Rituxan (rituximab) • cytarabine • ifosfamide • oxaliplatin • etoposide IV • vinorelbine tartrate • dexamethasone • Itari (linperlisib) • Duoenda (mitoxantrone liposomal)
6ms
CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma (clinicaltrials.gov)
P2, N=197, Not yet recruiting, The First Affiliated Hospital of Soochow University
New P2 trial
|
cyclophosphamide • Duoenda (mitoxantrone liposomal) • vindesine
7ms
VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT (clinicaltrials.gov)
P2, N=30, Recruiting, Institute of Hematology & Blood Diseases Hospital, China
New P2 trial
|
Venclexta (venetoclax) • cyclophosphamide • Duoenda (mitoxantrone liposomal)
7ms
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML (clinicaltrials.gov)
P2, N=34, Recruiting, First Affiliated Hospital of Zhejiang University
New P2 trial
|
Venclexta (venetoclax) • Duoenda (mitoxantrone liposomal)
7ms
CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma (clinicaltrials.gov)
P2, N=115, Recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial
|
cyclophosphamide • etoposide IV • vincristine • prednisone • Duoenda (mitoxantrone liposomal) • vindesine
8ms
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)
9ms
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)
9ms
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)
9ms
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)
10ms
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)
10ms
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)
10ms
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)
10ms
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)
10ms
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)
10ms
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)
10ms
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)
10ms
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)
10ms
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)
11ms
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)
11ms
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)
11ms
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)
11ms
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)
11ms
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)
11ms
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)
11ms
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)
11ms
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)
1year
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)
1year
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)
1year
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)
1year
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
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CD20 (Membrane Spanning 4-Domains A1)
|
gemcitabine • Rituxan (rituximab) • vinorelbine tartrate • Duoenda (mitoxantrone liposomal)
1year
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
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Venclexta (venetoclax) • Nailike (olverembatinib) • Synribo (omacetaxine mepesuccinate) • Duoenda (mitoxantrone liposomal) • Noxafil (posaconazole)
over1year
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)
over1year
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)
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