Floatz Rating
BB67/100
Confidence
Indicative
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
73High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07490288CT.gov Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML | — | Recruiting | — | — | — |
NCT07486479CT.gov Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML | — | Not Yet Recruiting | — | — | — |
NCT07108530CT.gov Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study | — | Recruiting | — | — | — |
NCT07028086CT.gov VAM in Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma | — | Recruiting | — | — | — |
NCT06758726CT.gov Mitoxantrone Hydrochloride Liposome Combined With BU/Cy Were Used as a Conditioning Regimen for Patients With Intermediate/Adverse Risk or Persistently Positive MRD AML | — | Not Yet Recruiting | — | — | — |
NCT06660368CT.gov BCL2i CLAG-M in R/R Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT07514936CT.gov Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia | — | Recruiting | — | — | — |
NCT06741722CT.gov Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML | — | Recruiting | — | — | — |
NCT06007911CT.gov Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia | — | Withdrawn | — | — | — |
NCT06621199CT.gov Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML | — | Recruiting | — | — | — |
Show 96 more trialsShow fewer
NCT06621212CT.gov Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML | — | Recruiting | — | — | — |
NCT06387069CT.gov A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT06447090CT.gov VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT | — | Recruiting | — | — | — |
NCT05904106CT.gov Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML | — | Recruiting | — | — | — |
NCT06434662CT.gov Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML | — | Recruiting | — | — | — |
NCT06499025CT.gov Treatment of Relapsed or Refractory t(8; 21) AML With Targeted AML1-ETO Neoantigen Cytotoxic T Cells (CTL) | — | Enrolling By Invitation | — | — | — |
NCT06345365CT.gov MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) | — | Recruiting | — | — | — |
NCT06221683CT.gov Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML | — | Recruiting | — | — | — |
NCT05941585CT.gov Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT05955261CT.gov A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia | — | Suspended | — | — | — |
NCT05330377CT.gov GM-CLAG in Relapsed/Refractory FLT3-mutated AML | — | Withdrawn | — | — | — |
NCT05603884CT.gov VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | — | Recruiting | — | — | — |
NCT05657639CT.gov CAV Regimen for R/R AML | — | Recruiting | — | — | — |
NCT05522192CT.gov Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT05345938CT.gov A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT04797767CT.gov Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms | — | Recruiting | — | — | — |
NCT05100303CT.gov A Study to Evaluate the Tolerance and Efficacy of Mitoxantrone Hydrochloride Liposome Injection Combined With Cytarabine in Patients With Acute Myeloid Leukemia (AML) | — | Unknown | — | — | — |
NCT04375631CT.gov CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia | — | Recruiting | — | — | — |
NCT04293562CT.gov A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | — | Recruiting | — | — | — |
NCT04195945CT.gov CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients | — | Active Not Recruiting | — | — | — |
NCT04196010CT.gov Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms | — | Terminated | — | — | — |
NCT03983824CT.gov Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT03926624CT.gov Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage | — | Terminated | — | — | — |
NCT03860844CT.gov Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT03591510CT.gov A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML | — | Active Not Recruiting | — | — | — |
NCT03839446CT.gov Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy | — | Completed | — | — | — |
NCT03735446CT.gov Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial | — | Terminated | — | — | — |
NCT03504410CT.gov Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML | — | Terminated | — | — | — |
NCT03531918CT.gov Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine & Mitoxantrone for Untreated AML & High-Grade Myeloid Neoplasm | — | Completed | — | — | — |
NCT03250338CT.gov Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML | — | Completed | — | — | — |
NCT03441048CT.gov Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03563560CT.gov A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03182244CT.gov A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation | — | Active Not Recruiting | — | — | — |
NCT03118466CT.gov Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT04024241CT.gov Medium Dose of Cytarabine and Mitoxantrone | — | Unknown | — | — | — |
NCT03164057CT.gov A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT03150004CT.gov Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) | — | Terminated | — | — | — |
NCT02462265CT.gov Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients | — | Suspended | — | — | — |
NCT03012672CT.gov Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm | — | Completed | — | — | — |
NCT02728050CT.gov Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT02298166CT.gov Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations | — | Terminated | — | — | — |
NCT02921061CT.gov Decitabine With GCLAM for Adults With Newly Diagnosed, Relapsed, or Refractory AML or High-Risk MDS | — | Completed | — | — | — |
NCT02756572CT.gov Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms | — | Completed | — | — | — |
NCT02631252CT.gov Phase I Study of Mitoxantrone and Etoposide Combined With Hydroxychloroquine, for Relapsed Acute Myelogenous Leukemia | — | Terminated | — | — | — |
NCT02724163CT.gov International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia | — | Recruiting | — | — | — |
NCT02520011CT.gov Alvocidib Biomarker-driven Phase 2 AML Study | — | Terminated | — | — | — |
NCT02198482CT.gov Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) | — | Terminated | — | — | — |
NCT02626338CT.gov Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML | — | Completed | — | — | — |
NCT02686593CT.gov Clofarabine, Cytarabine and Mitoxantrone (CLAM) for Relapsed or Refractory AML | — | Completed | — | — | — |
NCT02632708CT.gov Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation | — | Active Not Recruiting | — | — | — |
NCT02521493CT.gov Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome | — | Active Not Recruiting | — | — | — |
NCT02421939CT.gov A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation | — | Completed | — | — | — |
NCT02583893CT.gov Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02573363CT.gov Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02484391CT.gov CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma | — | Completed | — | — | — |
NCT02400281CT.gov Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients | — | Completed | — | — | — |
NCT02299518CT.gov Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02419755CT.gov Bortezomib and Vorinostat in Younger Patients With Refractory or Relapsed MLL Rearranged Hematologic Malignancies | — | Terminated | — | — | — |
NCT02306291CT.gov Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML | — | Completed | — | — | — |
NCT02070458CT.gov Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01904643CT.gov Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT02072811CT.gov Role of the Therapy Tailored to Risk Factors in Treating Adult Patients (≤60) With Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT02044796CT.gov Filgrastim, Cladribine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes | — | Completed | — | — | — |
NCT01830777CT.gov Brentuximab Vedotin + Re-induction Chemotherapy for AML | — | Completed | — | — | — |
NCT01801046CT.gov Donor Stem Cell Transplant in Treating Patients With High Risk Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT01842672CT.gov Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia | — | Completed | — | — | — |
NCT01768897CT.gov CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01729845CT.gov Decitabine Followed by Mitoxantrone Hydrochloride, Etoposide, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes | — | Completed | — | — | — |
NCT01681537CT.gov Lenalidomide Plus Chemotherapy for AML | — | Completed | — | — | — |
NCT01839240CT.gov Azacitidine, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With High-Risk Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01371981CT.gov Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01342887CT.gov Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT00906945CT.gov Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01249430CT.gov Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01260714CT.gov Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT01222143CT.gov Safety and Efficacy Study of Nilotinib Combined With Mitoxantrone, Etoposide, and High-dose Cytarabine Induction Chemotherapy Followed by Consolidation for Patients With C-kit Positive Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT01174888CT.gov Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01127009CT.gov Bortezomib, Mitoxantrone, Etoposide, and Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT01184898CT.gov Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML) | — | Completed | — | — | — |
NCT01027923CT.gov IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML) | — | Terminated | — | — | — |
NCT01587430CT.gov 3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia | — | Unknown | — | — | — |
NCT01382147CT.gov Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00634244CT.gov Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00660036CT.gov Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT06211452CT.gov Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00512252CT.gov AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00780104CT.gov Sirolimus in Combination With MEC in High Risk Myeloid Leukemias | — | Completed | — | — | — |
NCT00470197CT.gov Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Relapsed or Refractory Acute Leukemia | — | Completed | — | — | — |
NCT00744081CT.gov Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00143975CT.gov Gemtuzumab Ozogamicin in Combination With A-HAM in Refractory AML (GO-A-HAM) | — | Completed | — | — | — |
NCT00151255CT.gov All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT00180102CT.gov AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients <= 60 Years | — | Completed | — | — | — |
NCT00079482CT.gov Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00774046CT.gov High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML | — | Completed | — | — | — |
NCT00136084CT.gov Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia | — | Completed | — | — | — |
NCT00016016CT.gov Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Mitoxantrone (this asset) | Institute of Hematology & Blood Diseases Hospital, China | Approved | BB · 67 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Mitoxantrone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Acute Promyelocytic Leukemia | — | P4 | BBB · 77 |
| Acute Monocytic Leukemia | — | P2/3 | BBB · 74 |
| Myeloid Neoplasm | — | P3 | BBB · 74 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Mitoxantrone in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/mitoxantrone-acute-myeloid-leukemia
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