aclarubicin / Generic mfg. - LARVOL DELTA

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

Phase 2 study of chidamide in combination with CAG and venetoclax-azacitidine in older patients with newly diagnosed acute myeloid leukemia. (PubMed, Front Immunol) - P2 | "All patients received induction treatment with aclarubicin (10 mg/m2/d on days 1, 3, and 5), azacitidine (75 mg/m2 on days 1-7), cytarabine (75 mg/m2 bid on days 1-5), chidamide (30 mg, twice/week for 2 weeks), and venetoclax (100 mg on day 1, 200 mg on day 2, 400 mg on days 3-14). In conclusion, chidamide in combination with CAG and venetoclaxazacitidine was effective and well tolerated in elderly patients with AML. https://www.clinicaltrials.gov/, identifier NCT05659992."

Journal • P2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Gene Therapies • Hematological Malignancies • Infectious Disease • Neutropenia • Pneumonia • Respiratory Diseases • Septic Shock

Chidamide in Combination With DCAG With or Without Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia. (PubMed, Cancer Med) - P1 | "In conclusion, venetoclax in combination with CDCAG is an effective and safe treatment regimen for R/R AML, thereby rapidly identifying chemosensitive patients and inducing measurable residual disease-negative remission in a high proportion of patients with R/R AML."

Journal • Acute Myelogenous Leukemia • Cardiovascular • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Thrombosis

Aclacinomycin enhances the killing effect of allogeneic NK cells on acute myeloid leukemia cells by inducing immunogenic cell death. (PubMed, Front Immunol) - "These results demonstrated that allogeneic NK cells had enhanced functional responses when stimulated with ACM in vitro, exhibiting superior effector cytokine production and cytotoxicity compared to the control, which contained conventional NK cells. In conclusion, the present study suggested that the combination of ACM and allogeneic NK cells is a promising therapeutic strategy against AML."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • CALR • GZMB • HMGB1

A phase 2 study of chidamide in combination with CAG and venetoclax-azacitidine in acute myeloid leukemia: Clinical safety, efficacy, and correlative analysis. (PubMed, Int Immunopharmacol) - P2 | "Patients received induction treatment with aclarubicin (10 mg/m2/d on days 1, 3, and 5), azacitidine (75 mg/m2 on days 1-7), cytarabine (75 mg/m2 bid on days 1-5), chidamide (30 mg, twice/week for 2 weeks), and venetoclax (100 mg on day 1, 200 mg on day 2, 400 mg on days 3-14). In conclusion, this regimen resulted in a high CRc rate in newly diagnosed AML patients, particularly in adverse-risk patients. And this regimen had minimal impact on immune cells."

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

HSPG2 could promote normal haematopoiesis in acute myeloid leukaemia patients after complete remission by repairing bone marrow endothelial progenitor cells. (PubMed, Clin Transl Med) - "The HSPG2 level in the BM EPCs of AML-CR patients was decreased, which was related to the reduced BM EPC function. HSPG2 knockdown or Ara-C intervention reduced the HSPG2 level and led to BM EPC dysfunction, which could be restored by HSPG2 treatment in vitro. HSPG2 treatment restored the BM EPC function of AML-CR patients without affecting their leukaemia cell-supporting ability."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • HSPG2

Venetoclax and azacitidine in combination with homoharringtonine, cytarabine, and aclarubicin for salvage therapy of relapsed/refractory T cell acute lymphoblastic leukemia. (PubMed, Int J Hematol) - "VA-HAA may be an effective and safe salvage treatment for R/R T-ALL, and prospective clinical trials are needed to verify its specific clinical efficacy."

Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Serum stromal cell-derived factor 1α as a prognostic indicator in elderly patients with acute myeloid leukemia receiving CAG-based chemotherapy. (PubMed, Front Oncol) - "Patients received CAG (cytarabine, aclarubicin, and G-CSF)-based chemotherapy, and serum SDF-1α levels were assessed using ELISA. Elevated serum SDF-1α levels in elderly AML patients are associated with poor chemotherapy response and shorter survival. Baseline serum SDF-1α levels could serve as a prognostic marker for CAG-based treatment outcomes."

Biomarker • Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • CXCL12

Combination of Venetoclax and Daratumumab Plus CAG Regimen in Adult T-Cell Acute Lymphoblastic Leukemia with Persistent Positive Minimal Residual Disease (ASH 2024) - "Low-intensity CAG regimen was given as concurrent chemotherapy (Cytarabine 25mg/q12h day1~7, Aclarubicin 20mg/d day1~4, G-CSF 300μg/d day1~7). Our results suggest that comprehensive management, consisting of small molecular targeted drug, immunotherapy and low intensive chemotherapy followed by allo-HSCT, could be promising curative strategy in high-risk T-ALL. Nevertheless, this warrants further validation on a larger scale of T-ALL."

Clinical • IO biomarker • Minimal residual disease • Residual disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Oncology • T Acute Lymphoblastic Leukemia • Thrombocytopenia

Efficacy and Safety of Gilteritinib-Based Therapy Combinated with Allo-HSCT in Relapsed or Refractory Acute Myeloid Leukemia Patients with Positive FLT3-ITD Mutation (ASH 2024) - "Combination scheme including gilteritinib + venetoclax (Ven) ± azacitidine (AZA)/decitabine (DAC) (n=18), gilteritinib + Ven + DAC + Cladribine (n=1), gilteritinib + IA (idarubicin, cytarabine) (n=1) and gilteritinib + AZA + lower-dose HAAG regime (homoharringtonine, cytarabine, aclarubicin, G-CSF) (n=3). Additionally, gilteritinib maintenance therapy after allo-HSCT has demonstrated a significant enhancement in patients' survival. It is crucial to closely monitor and manage any adverse events that may occur during treatment."

Clinical • Acute Myelogenous Leukemia • Agranulocytosis • Anemia • Bone Marrow Transplantation • Febrile Neutropenia • Granulocytopenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Neutropenia • Oncology • Thrombocytopenia • FLT3

Phase Ⅱ Study of Chidamide in Combination with Dcag and Venetoclax for Refractory/Relapsed Acute Myeloid Leukemia: Clinical Safety, Efficacy, and Correlative Analysis (ASH 2024) - P1 | "Based on the demonstrated synergistic effects of BCL-2 inhibitor venetoclax with hypomethylating agents (HMAs) and our previously clinical trial results about CDCAG regimen, the combination therapy involving venetoclax and CDCAG, was investigated for patients with R/R AML.Patients and Methods : We conducted a phase 2 trial (ChiCTR2200065634) to assess the safety and efficacy of venetoclax, chidamide, azacitidine, aclarubicin, cytarabine and G-CSF (CDCAG+VEN) combination therapy in R/R AML patients...In prior treatments, patients received the following : the conventional "7+3" chemotherapy regimen (76.5%), hypomethylating agents such as azacitidine or decitabine (58.5%), venetoclax (38.2%) and chidamide (11.8%)...One patient experienced early death due to infectious shock within 19 days of starting treatment.ConclusionIn patients with R/R AML, the CDCAG + VEN regimen was well-tolerated and resulted in significant clinical benefit. Patients who have..."

Clinical • Combination therapy • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cardiovascular • Endocrine Disorders • Heart Failure • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • ASXL1 • TP53