mitoxantrone / Generic mfg. - LARVOL DELTA

COMMODORE: 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 (clinicaltrials.gov) - P3 | N=276 | Completed | Sponsor: Astellas Pharma Inc | Active, not recruiting ➔ Completed | Trial completion date: Mar 2027 ➔ Jul 2026

Trial completion • Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

NIR-II Small-Molecule Shuttle-Like Nanoassemblies for Mild-Temperature NIR-II Photothermal Enhanced Cuproptosis/STING Activation and Cancer Immunotherapy. (PubMed, Small) - "Herein, we report a multifunctional NIR-II phototheranostic agent (Cu-P/MTO@BTS) that integrates shuttle-like NIR-II small-molecule nanoassemblies with copper clusters (Cu-P) and the STING agonist mitoxantrone (MTO), enabling tumor immunotherapy via synergistic mild-temperature NIR-II PTT-enhanced cuproptosis and STING activation...Notably, the synergistic mild-temperature NIR-II PTT-enhanced cuproptosis and STING activation were found to promote immunogenic cell death (ICD), facilitate dendritic cell maturation, augment T-cell infiltration, and reverse the immunosuppressive tumor microenvironment. To summarize, the Cu-P/MTO@BTS nanoplatform developed herein exhibits robust antitumor therapeutic efficacy under both in vitro and in vivo conditions."

Journal • Metabolic Disorders • Oncology • STING

Venetoclax Plus High-Dose Cytarabine and Mitoxantrone (HAM-Ven) As Salvage Treatment for Relapsed/Refractory AML: Updated Results of the Phase-I/II SAL Relax Trial (ASH 2023) - P1/2 | "Enrollment into the RELAX trial is currently ongoing. Updated results will be presented at the meeting."

P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Neutropenia • Pneumonia • Respiratory Diseases • Septic Shock • PTPRC

Addition of Sorafenib to Cladribine, High-Dose Cytarabine, G-CSF, and Mitoxantrone (CLAG-M) in Adults with Newly-Diagnosed Acute Myeloid Leukemia (AML) and High-Grade Myeloid Neoplasms Independent of FLT3-Mutation Status: Final Results of a Phase 1/2 Study (ASH 2022) - P1/2 | "Addition of sorafenib to CLAG-M produces high rates of MRDneg CR in newly diagnosed AML patients ≤60 and prolongs OS and EFS in multivariate analysis compared to historical, matched control cohort receiving GLAG-M alone, a benefit that was particularly evident in patients with intermediate-risk disease."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Transplantation • CSF3 • FLT3

Cardiovascular and Survival Outcomes Among Adults With Hematologic Malignancies Receiving Anthracyclines With vs Without Dexrazoxane: A Real-World Propensity-Matched Analysis (SOHO 2026) - "Patients: Adults aged 18–75 years with a hematologic malignancy (ALL; AML; CLL; CML; Hodgkin lymphoma; DLBCL; follicular, mantle cell, or mature T/NK lymphoma; multiple myeloma; MDS; polycythemia vera) diagnosed on/after January 1, 2010, initiating an anthracycline (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone) within 3 months of diagnosis, with (n = 1887) or without (n = 40607) concurrent dexrazoxane. Dexrazoxane was paradoxically associated with higher cardiomyopathy, heart failure, MACE, and mortality, contrary to randomized cardioprotection trials. These results almost certainly reflect channeling bias: dexrazoxane is preferentially given to patients receiving high cumulative anthracycline doses or with preexisting/emerging cardiotoxicity, which are not captured by administrative coding. ALL: acute lymphoblastic leukemia, AML: acute myeloid leukemia, CLL: chronic lymphocytic leukemia, CML: chronic myeloid leukemia, DLBCL: diffuse large B-cell..."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Polycythemia Vera

Follow-up of the Randomized ASAP Trial Shows No Survival Advantage for Patients with Poor Responsive or Relapsed AML Who Received Intensive Salvage Chemotherapy for Remission Induction Prior to Allogeneic Transplantation Compared to Immediate Allogeneic Transplantation (ASH 2024) - P3 | "METHODS To test salvage chemotherapy prior to alloHCT, patients aged between 18 and 75 years with AML and poor response after first induction or untreated first relapse and available HLA-compatible donor were randomized 1 : 1 to remission induction (RIST) with high-dose cytarabine plus mitoxantrone or immediate alloHCT with sequential conditioning after disease control (DisC). More potent bridging concepts with targeted drugs prior to alloHCT are warranted especially for adverse risk AML and need to be tested in RCTs to demonstrate sustained survival advantage. Together with the profound impact of genetic risk on long-term survival the results may be interpreted as a sign that patients with poor responsive or relapsed AML benefit rather from relapse prevention after alloHCT than conventional CR induction prior to alloHCT."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • Transplantation • TP53

GILTERITINIB VERSUS MIDOSTAURIN IN PATIENTS WITH NEWLY DIAGNOSED FLT3-MUTATED ACUTE MYELOID LEUKEMIA ELIGIBLE FOR INTENSIVE THERAPY: RESULTS FROM THE PHASE 3 HOVON156/AMLSG28-18/PASHA TRIAL (EHA 2026) - P3 | "Pts were randomized to induction chemo (cycle 1: standard 7+3 [cytarabine + anthracycline]; cycle 2: daunorubicin + intermediate-dose cytarabine) + either oral GILT (120 mg once daily) or MIDO (50 mg twice daily) on days 8–21. Consolidation for pts in complete remission (CR), CR with incomplete hematologic recovery (CRi) or morphologic leukemia free state (MLFS) consisted of chemo (intermediate-dose cytarabine or mitoxantrone/etoposide) + GILT or MIDO; or autologous/allogeneic hematopoietic stem cell transplantation (auto/alloHSCT) with GILT or MIDO maintenance for 1 y. Eligible pts (≥18 y) had ND FLT3 mut+ AML, ECOG PS ≤2 and were fit for intensive chemo...Summary/Conclusion Survival outcomes for GILT were not significantly different from MIDO in ND FLT3 mut+ AML, thus the primary endpoint was not met. A clinically meaningful RFS advantage with GILT vs MIDO did not translate into an OS benefit, likely due to more frequent use of GILT and alloHSCT as salvage therapy..."

Clinical • Late-breaking abstract • P3 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • FLT3 • NPM1

Study of Mitoxantrone, Cytarabine and Lisaftoclax Combination Therapy for Newly Diagnosed Adult Acute Myeloid Leukemia (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: The first affiliated hospital of guangzhou university of Chinese medicine; The first affiliated hospital of guangzhou university of Chinese medicine

New P2 trial • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

VENETOCLAX-BASED SALVAGE TREATMENT FOR RELAPSED/REFRACTORY AML USING A COMBINATION WITH HIGH-DOSE CYTARABINE AND MITOXANTRONE (HAM-VEN): UPDATED RESULTS OF THE PHASE-I/II SAL RELAX TRIAL (EHA 2024) - P1/2 | "The combination of venetoclax with high-dose cytarabine and mitoxantrone (HAM-Ven) is a safe, well-tolerated and very efficacious treatment option, leading to complete remissions in 75% of pts with r/r AMLstudied in the RELAX trial. Safety and efficacy compare favorably with published results from the FLAG-Ida-Venregimen, thereby providing a less dose-intense, fludarabine-free approach for treatment of fit r/r AML pts. Updated results will be presented at the meeting."

P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Neutropenia • Pneumonia • Respiratory Diseases • Septic Shock • PTPRC

LONG-TERM FOLLOW-UP OF PREDOMINANTLY ASIAN PATIENTS WITH RELAPSED/REFRACTORY FLT3-MUTATED ACUTE MYELOID LEUKEMIA TREATED WITH GILTERITINIB VERSUS SALVAGE CHEMOTHERAPY IN THE PHASE 3 COMMODORE TRIAL (EHA 2025) - P3 | "In this phase III, open-label, multicenter study, patients with R/R FLT3mut+ AML from 48 sites in China, Malaysia, Thailand, Singapore and Russia, were randomized 1:1 to gilteritinib (120 mg/day) or SC (low-dose cytarabine; mitoxantrone, etoposide, and intermediate-dose cytarabine; or fludarabine, high-dose cytarabine, and granulocyte colony-stimulating factor). With a median follow-up of over 3 years, gilteritinib improved clinical outcomes compared with SC and was well-tolerated in a predominantly Asian population with R/R FLT3mut+ AML, consistent with the results from the primary analysis, further supporting its long-term use."

Clinical • P3 data • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Bone Marrow Transplantation • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

Coupled equilibria characterizing the binding of the anticancer drug mitoxantrone to a dendritic molecular basket. (PubMed, Chem Commun (Camb)) - "A polyanionic and dendritic molecular basket forms a stable (µM) inclusion complex with the dicationic anticancer drug mitoxantrone in aqueous solution at physiological pH."

Journal • Oncology

Lintuzumab-Ac225 with Combination with Intensive Chemotherapy Yields High Response Rate and MRD Negativity in R/R AML with Adverse Features (ASH 2022) - "Induction consisted of G-CSF, 300mcg/d, given D1-6, cladribine 5mg/m2, given D2-6, cytarabine 2g/m2, given D2-6, and mitoxantrone 10mg/m2, given D2-4. Actimab-A at 0.75uCi/kg, combined with CLAG-M is feasible and safe, and this combination demonstrates a high response rate and MRD negativity in a high-risk AML population. Pharmacokinetics at the RP2D indicate rapid drug clearance. Furthermore, responses appear durable, particularly among patients who are able to proceed to alloHCT."

Minimal residual disease • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Mucositis • Neutropenia • CD33 • CSF3 • MCL1 • TP53

Utilization of Terephthalic Acid Obtained From Textile Waste for Environmental Detection of Mitoxantrone Using Molecularly Imprinted Electrochemical Sensor Technology. (PubMed, Electrophoresis) - "Both computational and experimental results identified the 1:1 ratio as optimal. The developed MIP-based sensor achieved a detection limit of 2.13 × 10-13 M. These findings demonstrate the potential of converting textile waste into high-value functional materials for advanced environmental monitoring and analytical applications."

Journal • Oncology

Outpatient Low-Dose Venetoclax Plus Azacitidine Vs. Intensive Chemotherapy for Newly Diagnosed Fit Patients with Acute Myeloid Leukemia in a Limited Resource Setting (ASH 2023) - P2 | "Low-dose Ven/Aza was administered as follows: venetoclax 100 mg QD fixed dose plus itraconazole 100 mg BID for 21 days per cycle, and azacitidine 100 mg SC fixed dose QD or 7 days, 1-2 cycles. IC patients received 7+3 or intermediate dose cytarabine plus 3 days of mitoxantrone... in this single-center study, AML patients treated in a limited resource setting with low-dose Ven/Aza had similar complete response and survival to IC with reduced complications and shorter hospital stay, despite being older with higher risk disease. This induction treatment is a low-cost but effective option in a LMIC environment and could be considered an alternative option, even in suitable candidates for IC, especially with access to HCT."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Novel Coronavirus Disease • Oncology • Transplantation

Evaluation of Venetoclax Impact Through Retrospective Survival Rate Analysis in Adult Patients With Acute Myeloid Leukemia in Induction With Intensive Chemotherapy as Second Line of Treatment (SOHO 2026) - "Intervention: Administration of venetoclax combined with salvage IC protocols (FLAG regimen—fludarabine, arabinosyl cytosine, and granulocyte-colony stimulating factor—combined with anthracycline or mitoxantrone). Within this limited study, venetoclax combined with IC was associated with an improved prognosis compared with chemotherapy alone in patients needing salvage therapy. These specific findings suggest that venetoclax provides better outcomes and cost-effectiveness. This study fully showcases the necessity to reform Brazil's public health system by including venetoclax as a second-line induction treatment for adults."

Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Remission induction versus immediate allogeneic haematopoietic stem cell transplantation for patients with relapsed or poor responsive acute myeloid leukaemia (ASAP): a randomised, open-label, phase 3, non-inferiority trial. (PubMed, Lancet Haematol) - P3 | "Non-inferiority of disease control could not be shown at the 2·5% significance level. The rate of treatment success was also not statistically better for patients with remission induction. Watchful waiting and immediate transplantation could be an alternative for fit patients with poor response or relapsed acute myeloid leukaemia who have a stem cell donor available. More randomised controlled intention-to-transplant trials are needed to define the optimal treatment before transplantation for patients with active acute myeloid leukaemia."

Head-to-Head • Journal • P3 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Oncology • Transplantation

Venetoclax combined with high-dose cytarabine and mitoxantrone for relapsed or refractory acute myeloid leukemia: outcomes and risk stratification. (PubMed, Haematologica) - "Patients without these features had a 1-year OS of 73%. HAM plus VEN retains high efficacy and encouraging survival outcomes in a real-world setting, supporting its use as an effective salvage and bridge-to-transplant strategy."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • TP53

AI-Guided Discovery of Natural-Product-Inspired Scaffolds as Dual P-gp/BCRP Inhibitors to Overcome Cancer Multidrug Resistance. (PubMed, J Med Chem) - "In xenografts, Ib18 enhanced the antitumor activity and tumor accumulation of mitoxantrone without detectably increasing systemic toxicity. Together, these findings demonstrate the utility of AI-guided molecular design for overcoming MDR and establish a promising natural-product-inspired chemotype for dual P-gp/BCRP inhibitor."

Journal • Breast Cancer • Oncology • Solid Tumor • ABCB1 • ABCG2

Vincristine Sulfate Liposome Injection with Combination Chemotherapy for Children, Adolescents, and Young Adults with Relapsed Acute Lymphoblastic Leukemia: A Therapeutic Advances in Childhood Leukemia and Lymphoma Consortium Trial. (PubMed, Pediatr Blood Cancer) - P1 | "Based on the promising response signal in this heavily pretreated population, further study of VSLI is warranted. (ClinicalTrials.gov NCT02879643)."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology

TUD-RELAX1-070: Trial for Relapsed or Refractory AML Patients Combining Cytarabine and Mitoxantrone With Venetoclax (RELAX) (clinicaltrials.gov) - P1/2 | N=55 | Completed | Sponsor: Technische Universitt Dresden | Active, not recruiting ➔ Completed

Trial completion • Acute Myelogenous Leukemia

Amine oxide lipid nanoparticles for delivery of cyclic dinucleotides. (PubMed, Natl Sci Rev) - "In line with growing emphasis on combination therapy in oncology, we further incorporate lipidated mitoxantrone in the LNP as an inducer of immunogenic cell death to enhance tumor antigen presentation and STING-driven immunotherapy. The obtained LNP provokes potent immunostimulatory and antitumor effects in multiple challenging animal models, including triple-negative breast cancer, pancreatic cancer and melanoma."

Journal • Breast Cancer • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • STING

MRD-positive AML Clinical Study (clinicaltrials.gov) - P=N/A | N=537 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | N=120 ➔ 537 | Trial completion date: Apr 2028 ➔ Oct 2028 | Trial primary completion date: May 2026 ➔ May 2028

Enrollment change • Minimal residual disease • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • DEK • FLT3 • NPM1 • NUP214 • RUNX1 • RUNX1T1

Disease risk but not remission status determines transplant outcomes in AML: long-term outcomes of the ASAP trial. (PubMed, Blood) - P3 | "In total 281 patients with AML with poor response after first induction or untreated first relapse were randomized 1:1 to remission induction (RIST) with high-dose cytarabine plus mitoxantrone versus immediate alloHCT with sequential conditioning after non-intensive disease control measures (DisC) preferentially watchful waiting only. Well tolerable novel bridging therapies and post-transplant maintenance with targeted drugs are urgently warranted, especially for adverse-risk AML, to improve outcome after alloHCT. NCT02461537."

Journal • Acute Myelogenous Leukemia • Transplantation

Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Acute Myeloid Leukaemia. (PubMed, EJHaem) - P2 | "This phase 2 study evaluated magrolimab+venetoclax (VEN)+azacitidine (AZA) in untreated, unfit acute myeloid leukaemia (AML) and magrolimab+mitoxantrone+etoposide+cytarabine in relapsed/refractory (R/R) AML. Magrolimab was safely combined with existing AML therapies with no new safety signals. This trail was registered at www.clinicaltrials.gov as NCT04778410."

Journal • P2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Survival and Toxicity Trade-Offs With Anthracycline-Based Induction vs Non-Anthracycline Therapy in Newly Diagnosed Acute Myeloid Leukemia: A Real-World Propensity-Matched Analysis (SOHO 2026) - "Anthracycline cohort (n = 9727): daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone. Nonanthracycline cohort (n = 6649): azacitidine, decitabine, venetoclax, glasdegib, gilteritinib, enasidenib, ivosidenib, midostaurin; anthracyclines excluded... Anthracycline induction was associated with 27% lower 3-year mortality but higher acute toxicity—36% more hospitalization, 23% bleeding, 13% VTE, 11% MACE—reflecting the risk-benefit profile of intensive induction. Selection of fitter patients with favorable AML biology likely contributes through residual confounding despite PSM. These findings reinforce integrating fitness, cytogenetic/molecular risk, and patient preference into the frontline regimen choice."

Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3