aclarubicin / Generic mfg. - LARVOL DELTA

Venetoclax-azacitidine-chidamide plus CAG (CACAG-VEN) versus "3+7" induction chemotherapy in Intermediate-adverse Acute Myeloid Leukemia: Efficacy and safety (ASH 2025) - "MethodsIn this phase 2 clinical trial, we aimed to investigate the efficacy and safety of venetoclax-azacitidine incombination with chidamide and CAG (cytarabine, aclarubicin, granulocyte colony-stimulating factor),named as CACAG-VEN, in intermediate-adverse AML across 6 centers in China. The most common grade 3-4 non-hematologic adverse events in both groups were febrileneutropenia and pulmonary infection, with no significant differences in both groups. It achieved fasterneutrophil recovery to ≥1000/μL (median 19 vs. 20 days, P = 0.047) and earlier platelet reconstitution(≥20,000/μL: 16 vs. 18 days, P =0.001).ConclusionAmong intermediate and adverse-risk AML patients, the CACAG-VEN demonstrated superior responserates over "3+7" regimen, along with faster hematologic recovery."

Clinical • Acute Myelogenous Leukemia • Febrile Neutropenia • Infectious Disease • Neutropenia • Respiratory Diseases

Venetoclax-azacitidine in combination with chidamide and CAG versus daunorubicin and cytarabine in newly diagnosed AML (ASH 2025) - P2 | "Through drug synergy analysis,we demonstrated that the multiple epigenetic agents combined with cytarabine and aclarubicinsynergistically induced significantly faster and deeper apoptosis compared to monotherapy. It achieved faster neutrophil recovery to≥1000/μL (median 19 vs 21 days, P = 0.020) and earlier platelet reconstitution (≥20,000/μL: 15 vs 17 days,P <0.001; ≥50,000/μL: 16 vs 17 days, P =0.023).ConclusionIn conclusion, CACAG+VEN demonstrated superior response rates and improved EFS over DA in newlydiagnosed AML patients across different genetic groups, with superior safety. The trial was registered atClinicalTrials.gov as #NCT06068621."

Combination therapy • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Respiratory Diseases • RUNX1 • RUNX1T1

Targeting CPNE8 suppresses HOXA9-dependent AML progression and overcomes chemotherapy resistance (ASH 2025) - "CPNE8-high PBMCs showed significantly elevated IC50 values across a range of clinicallyrelevant chemotherapeutics, including idarubicin, homoharringtonine, fludarabine, azacitidine,venetoclax, aclarubicin, all-trans retinoic acid (ATRA), and mitoxantrone. Importantly, both Menin inhibition and CPNE8 knockdown prolonged survival in CPNE8-high AMLxenograft models, underscoring their therapeutic potential.ConclusionCPNE8 functions as a critical downstream effector of HOXA9, driving AML progression and therapyresistance through activation of Rap1 signaling, reprogramming of mitochondrial metabolism, andreshaping of the immune microenvironment. Blocking the HOXA9–CPNE8–Rap1 pathway, especially withMenin inhibitors, provides a rationale for stratified treatment strategies in CPNE8-high AML."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • HOXA9

Vennetoclax combined with decitabine, cytarabine, aclacinomycin and granulocyte colony-stimulating factor as induction regimen achieved high response rate in newly diagnosed adverse risk Acute Myeloid Leukemia (ASH 2025) - P4 | "Weintenteded to enrolled 38 patients (pts) who would receive venetoclax (VEN) combined with decitabine(DEC), cytarabine (Ara-C), aclacinomycin (Acla) and granulocyte colony-stimulating factor (G-CSF) (DCAG).VEN was orally taken 100mg on day 1,200mg on day 2 and 400mg on days 3 to 12. Between October 2023 to April 2025, 40 patients (pts) were enrolled in this study. The medianfollow-up time was 6 (2.4-20.8) months.The median age was 54 (21-72) years, in which 72.5% (29/40) pts were less than 60 years, and 57.5%(23/40) pts were male. There were 12.5% (5/40) pts with preceding hematological disease, and 5% (2/40)pts with malignant tumor treatment."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Solid Tumor • KMT2A • NUP214 • NUP98 • TOP1 • TP53

Anthracyclines attenuate Nrf1-dependent proteolytic pathways and potentiate proteasome inhibitor cytotoxicity. (PubMed, Mol Biol Cell) - "Proteasome inhibitors such as bortezomib, carfilzomib, and ixazomib are FDA-approved treatments for multiple myeloma, but resistance frequently limits their effectiveness...Importantly, aclarubicin, a non-DNA-damaging anthracycline, also attenuated Nrf1 transcriptional activity, indicating that DNA damage is not required for this inhibition. Doxorubicin co-treatment delayed proteasome recovery after pulse inhibition and partially restored sensitivity to carfilzomib in bortezomib-resistant U266 myeloma cells, consistent with genetic knockout of Nrf1. These findings identify a DNA-damage-independent mechanism by which anthracyclines directly obstruct Nrf1-mediated transcriptional induction. Thus, anthracyclines serve as chemical tools to probe the molecular control of proteostasis and suggest a strategy to mitigate Nrf1-driven adaptive response to proteasome inhibition."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology • NRF1

Venetoclax combined with homoharringtonine, cytarabine and aclacinomycin as induction therapy in newly diagnosed Chinese acute myeloid leukaemia patients: A multicentre phase II study. (PubMed, Br J Haematol) - "With a median follow-up of 15.5 months, the -1-year overall survival was 77.9% (95% CI 18.3-26.1), relapse-free survival was 83.9% (95% CI 19.2-22.3) and event-free survival was 71.3% (95% CI 16.9-20.5). The HAAV regimen is highly efficacious and safe for newly diagnosed AML patients."

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

Comparative Analysis of the Therapeutic Efficacy of Decitabine Combined with Cytarabine, Aclarubicin, and Granulocyte Colony-stimulating Factor (D-CAG) Versus CAG Regimen in the Treatment of Acute Myeloid Leukemia. (PubMed, Indian J Hematol Blood Transfus) - "Compared to the CAG regimen alone, the combination of decitabine and CAG regimen enhanced the therapeutic efficacy in AML patients without significantly increasing adverse reactions or toxic side effects, demonstrating commendable safety. Furthermore, the combined treatment regimen may improve immune function to some extent, potentially playing a positive role in controlling AML progression."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Oncology • IL4

Venetoclax plus hypomethylating agents versus priming regimen as the first-line therapy for newly diagnosed acute myeloid leukemia with myelodysplasia-related changes: a propensity score-matched analysis. (PubMed, Leuk Lymphoma) - "Venetoclax-based regimens are approved for such patients, while studies suggest priming regimens combining aclarubicin, homoharringtonine or idarubicin and low-dose cytarabine with granulocyte colony-stimulating factor may replace intensive therapy, while direct comparisons are lacking in two groups. Multivariate analysis confirmed VEN+HMA as an independent predictor of better ORR (OR = 2.855, p = 0.014), OS (HR = 0.449, p = 0.036), and EFS (HR = 0.458, p = 0.003). These findings suggest VEN+HMA may be a preferable low-intensity induction therapy over priming regimens for AML-MR."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

DNA intercalating drugs: Mechanisms of action in cancer treatment. (PubMed, Adv Biol Regul) - "Doxorubicin and aclarubicin are used clinically to treat cancer, while BMH-21 remains in preclinical development. Reports on plasma pharmacokinetics of these anthracyclines will be tabulated, and the clinical relevance of the observed mechanisms of action for doxorubicin and aclarubicin will be assessed based on this information."

Journal • Review • Oncology • Targeted Protein Degradation • TOP1

Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Chinese PLA General Hospital | Trial completion date: Jan 2026 ➔ Aug 2025

Trial completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

KMHD-01: A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients (clinicaltrials.gov) - P2 | N=114 | Completed | Sponsor: Hematology department of the 920th hospital | Recruiting ➔ Completed | Phase classification: P1/2 ➔ P2 | Trial completion date: Sep 2024 ➔ Apr 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Various anthracyclines exhibit differential cytotoxic effects related to CBR1-induced resistance in lung cancer cells. (PubMed, Med Oncol) - "The role of CBR1 in cancer resistance against five anthracyclines: doxorubicin, daunorubicin, epirubicin, idarubicin, and aclarubicin, was examined in A549 lung cancer cells transduced with the CBR1. Surprisingly, aclarubicin was the most dependent on CBR1 among the tested compounds, while it exhibited a low reaction velocity when catalyzed by recombinant CBR1. The findings reveal critical differences in anthracycline susceptibility to CBR1, offering insights into resistance mechanisms."

Journal • Addiction (Opioid and Alcohol) • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Stage-specific target mining and drug repurposing to confront cervical cancer progression: Insight into molecular aberrations of precancerous lesions to invasive cancer (ESMO-GC 2025) - "Conclusions The study uncovers key genetic underpinnings driving CxCa progression and highlights citicoline, valtorcitabine, and aclarubicin as potential repurposable drugs. Legal entity responsible for the study K.S. Satish."

Cervical Cancer • Oncology • Solid Tumor • APOBEC3B • AURKA • CDK1 • CENPA • KIF11 • TOP2A • YTHDF2

DECITABINE COMBINED WITH HAAG FOR NEWLY DIAGNOSED PARENTS WITH POOR-RISK ACUTE MYELOID LEUKEMIA: A PROSPECTIVE, PHASE 3, RANDOMIZED, MULTI-CENTER STUDY (EHA 2025) - P3 | "The combination of venetoclax and the hypomethylating agent azacitidine has been the front-line induction chemotherapy in unfit AML patients,results in a remission rate of approximately 60%...Between April 2019-December 2022, 33 treatment-naïve AML patients (ELN 2017 adverse-risk) were randomized to receive either(2:1):Experimental arm (n=23):Decitabine 20 mg/m²/d IV days 1-5; Homoharringtonine 1 mg/d IV days 3-16; Aclarubicin 10 mg/d IV days 3-10; Cytarabine 10 mg/m² q12h days 3-16; G-CSF 50-300 μg/d SC days 2-16Control arm (n=10):Idarubicin 12 mg/m²/d IV days 1-3; Cytarabine 100 mg/m²/d CIV days 1-7.Consolidation included 1 cycle of induction regimen for CR patients, followed by HDAC (3 g/m² q12h days 1-3) for 1-2 cycles pre-HSCT or 3-4 cycles for non-transplant candidates... This interim analysis demonstrates DAC+HAAG induces numerically higher CRc rates (65.2% vs 40%) with comparable toxicity to standard IA in high-risk AML,the..."

Clinical • P3 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Infectious Disease • Neutropenia • Thrombocytopenia

REAL-WORLD TREATMENT PATTERNS AND CLINICAL OUTCOMES IN PATIENTS WITH AML FROM 65 TO 74 YEARS UNFIT FOR FIRST-LINE INTENSIVE CHEMOTHERAPY IN JAPAN. (EHA 2025) - "Although venetoclax (VEN) combinations are recommended for IC-ineligible AML patients due to age or comorbidities, there is limited real-world data comparing VEN-regimens to other lower-intensity therapies, such as reduced IC and the cytarabine, aclarubicin, and granulocyte colony-stimulating factor (CAG) regimen, historically used in Japan...In the pre-VEN era (n=46), the most frequent 1st line therapy was reduced dose of 7+3 (r7+3: idarubicin or daunorubicin + cytarabine)(n=22, 47.8%), followed by azacytidine (AZA) (n=11, 23.9%) and CAG (n=9, 19.6%) (Fig 1A left)... Despite the higher number of patients with CK and TP53 mutation, OS and response rates of VEN+AZA group were comparable to r7+3 and early mortality at 60 days were lower."

Clinical • Clinical data • HEOR • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Septic Shock • FLT3 • TP53

COMBINATION OF VENETOCLAX AND DARATUMUMAB PLUS CAG REGIMEN IS AN EFFECTIVE TRANSPLANT BRIDGING REGIMEN IN ADULT T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WITH POSITIVE MINIMAL RESIDUAL DISEASE (EHA 2025) - "CAG regimen was given (Cytarabine 25mg/q12h day1-14, Aclarubicin 20mg/d day1-4, G-CSF 300μg/d day1-14). The DV-CAG regimen is safe and effective to rapidly eradicate leukemia cells in both CR with MRD(+) and relapsed T-ALLs. Subsequent transplantation is recommended to achieve long-term survival. Our result warrants further validation on a larger scale of T-ALL cohort."

Clinical • IO biomarker • Minimal residual disease • Residual disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Leukopenia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Thrombocytopenia • Transplantation • CD7

HOW TO IMPROVE THE EFFICACY OF VENETOCLAX AND AZACITIDINE(VA)FOR AML WITH A MONOCYTIC PHENOTYPE? (EHA 2025) - "In this prospective study, we evaluated the efficacy and safety of venetoclax, azacitidine combined with HAAG or liposomal mitoxantrone (Lipo-MIT) as induction therapy in patients with newly diagnosed AML...Regimens:VA+HAAG (n=14): Venetoclax (ramp-up: 100-400 mg, days 1-10), azacitidine (75 mg/m², days 1-7), HHT (1 mg/d, days 4-10), aclarubicin (10 mg/d, days 4-7), cytarabine (10 mg/m² q12h, days 4-10), and G-CSF (50-300 µg/d, days 3-10).VA+Lipo-MIT (n=5): Venetoclax (same dosing), azacitidine (same dosing), Lipo-MIT (24 mg/m², day 1).Endpoints: Primary: Overall response rate (ORR: CR/CRi)... In conclusion, the VA combined with HAAG or Lipo-MIT regimen was effective and well-tolerated as induction therapy in patients with newly diagnosed AML. Moreover, this novel regimen demonstrated a higher CR rate in patients with FAB-M4/M5 subtype compared to the VA regimen."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Infectious Disease • Neutropenia • Septic Shock • Thrombocytopenia • CBFB • DEK • DNMT3A • FLT3 • KMT2A • MCL1 • NRAS • NSD1 • NUP214 • NUP98 • PTPN11

A PHASE 2 STUDY OF CHIDAMIDE IN COMBINATION WITH CAG AND VENETOCLAX-AZACITIDINE IN ELN ADVERSE-RISK ACUTE MYELOID LEUKEMIA (EHA 2025) - "Aims: A phase 2 study was conducted to evaluate the clinical safety and efficacy of chidamide combined with cytarabine, aclarubicin, and granulocyte colony-stimulating factor and venetoclax-azacitidine (CACAG-VEN) as first-line therapy in ELN 2022 adverse-risk AML patients (n = 28). The CACAG-VEN regimen for ELN 2022 adverse-risk AML patients exhibited a high ORR and satisfactory safety as first-line therapy, providing a potential induction therapy for these patients."

Combination therapy • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Gene Therapies • Infectious Disease • Neutropenia • Pneumonia • Respiratory Diseases • Septic Shock

THE SAFETY AND EFFICACY OF SONROTOCLAX COMBINED WITH AZACITIDINE (AZA) AND HAG IN PATIENTS (PTS) WITH REFRACTORY/ RELAPSED (R/R) ACUTE MYELOID LEUKEMIA (AML): A PHASE II STUDY (EHA 2025) - "Venetoclax (VEN) combined with hypomethylating agents (HMA) have been the standard treatment for newly diagnosed unfit AML pts...VEN plus HMA and CAG (aclarubicin, cytarabine, G-CSF) for R/R AML achieved a CR/CRi rate of 85%, allo-HSCT rate of 55% and 1-year OS rate of 60% (Liu Y et al, 2023)...HAG (homoharringtonine, cytarabine, G-CSF), a priming regimen, is an effective and safe treatment commonly used in Asia for R/R AML...Maintenance includes a 28-day cycle of sonrotoclax combined with AZA until intolerable toxicity, 10 months, recurrence, death, withdraw informed consent or study termination determined by investigator.The primary endpoint is 1-year OS rate assessed by investigator. The secondary endpoints include OS, CRc rate at the end of induction, MRD negative rate (MRD <0.1% by MFC), DOR, EFS, RFS and safety."

Clinical • P2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • ENG

VENETOCLAX PLUS DECITABINE, CYTARABINE, ACLARUBICIN, AND G-CSF IN ADULTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA: A MULTICENTER, RETROSPECTIVE STUDY (EHA 2025) - "The VD-CAG regimen represents an effective induction therapy for newly diagnosed adults with AML. It leads to high rates of CRc and MRD-negative remissions, along with encouraging OS and EFS across prognostic subgroups."

Retrospective data • Acute Myelogenous Leukemia • Anemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia

Determining preclinical safety of Aclarubicin in pediatric malignancies. (PubMed, bioRxiv) - "We evaluated the anti-tumor efficacy and safety profile of Acla in multiple in vitro pediatric cancer models and in vivo mouse models designed to mimic anthracycline re-treatment following prior doxorubicin (Doxo) exposure. These results support continued investigation of chromatin-damaging anthracyclines that can kill pediatric cancer cells without inducing genotoxic stress. In addition, our studies underscore the need to refine preclinical models to better understand both acute and chronic anthracycline toxicities in pediatric and adolescent populations."

Journal • Preclinical • Cardiovascular • Oncology • Pediatrics

A multicenter, prospective, randomized controlled study of the standard "3+7" regimen versus Venetoclax combined with CACAG regimen in newly diagnosed adult patients with intermediate- and high-risk acute myeloid leukemia (ChiCTR) - P=N/A | N=160 | Recruiting | Sponsor: The Fifth Medical Center of the General Hospital of the People's Liberation Army.; The Fifth Medical Center of the General Hospital of the People's Li

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

Potent immune-dependent anticancer effects of the non-cardiotoxic anthracycline aclarubicin. (PubMed, Oncoimmunology) - "Aclarubicin induces much less DNA damage than the classical anthracyclines doxorubicin, daunorubicin, epirubicin, idarubicin, and the anthracene mitoxantrone, but is equally effective in inhibiting DNA-to-RNA transcription and in eliciting immunogenic stress in malignant cells. As a result, we advocate for clinical studies seeking to replace the anthracyclines used in Western medicine by aclarubicin-like compounds. Such clinical studies should not only embrace hematological malignancies but should also concern solid cancers, including those in which ICD-inducing chemotherapies are followed by immunotherapies targeting the PD-1/PD-L1 interaction."

Journal • Review • Acute Myelogenous Leukemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Chinese PLA General Hospital

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

Key Technical Research on CACAG Combined with Venetoclax for the Treatment of Elderly Patients with Primary Acute Myeloid Leukemia (ChiCTR) - P2 | N=50 | Recruiting | Sponsor: The Fifth Medical Center of the General Hospital of the People's Liberation Army; The First Medical Center of the General Hospital of the People's Lib

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