aclarubicin / Generic mfg. - LARVOL DELTA

Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Chinese PLA General Hospital | Phase classification: P2 ➔ P3

Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Venetoclax plus azacitidine, low-dose cytarabine, aclarubicin, and G-CSF (VA-CAG regimen) for newly diagnosed young patients with acute myeloid leukemia: A prospective, multicenter, single-arm Phase II clinical trial. (PubMed, Hemasphere) - "The median DOR values of all patients and the patients who did not receive HSCT were not reached. Hence, the VA-CAG regimen is a safe and effective first-line induction chemotherapy for ND-AML patients."

Journal • P2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Colorectal Cancer • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia • Transplantation

Histone deacetylase inhibitors as venetoclax-sensitising partners in acute myeloid leukaemia: Mechanisms, pharmacology and translational perspectives. (PubMed, Br J Pharmacol) - "Early HDAC inhibitor-containing composite regimens, particularly chidamide-based CACAG-VEN (chidamide, venetoclax, azacitidine, low-dose cytarabine, aclarubicin and granulocyte colony-stimulating factor), report high response rates, including overall response rate of 76.5-98.0%, complete remission/complete remission with incomplete count recovery or composite complete remission of 73.5-93.3%, and measurable residual disease negativity of 44-61%. Future development should prioritise biomarker-selected trials that hold non-HDAC components constant, incorporate pharmacodynamic HDAC engagement and BH3 profiling, and account for cytochrome P450 3A-mediated drug interactions. HDAC inhibitor-venetoclax combinations are mechanistically rational, but standard-of-care positioning requires randomised or pharmacodynamic validation."

IO biomarker • Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BCL2 • HDAC1

Initial preclinical investigation of aclarubicin treatment in primary cutaneous T-cell lymphoma cells. (PubMed, JID Innov) - "Anthracyclines, including doxorubicin, are such drugs, but they are associated with cardiotoxicity that limits treatment. Under a 2-hour pulse exposure that mimics the serum pharmacokinetics of these drugs, aclarubicin was less toxic, with an 8-20-fold lower half-maximal inhibitory concentration than those of the other anthracyclines tested, yet it demonstrated superior ex vivo cytotoxicity under T-cell activation. Aclarubicin should be considered for further preclinical and clinical evaluation in cutaneous T-cell lymphoma."

Journal • Preclinical • Cardiovascular • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD4

Anthracycline Cardiotoxicity: A Real-World Study Based on FDA Adverse Event Reporting System Database. (PubMed, Cardiovasc Ther) - "This study provides a more comprehensive insight into the monitoring, supervision, and management of adverse reactions related to anthracyclines. Clinicians should further focus on the impact of various AEs related to anthracyclines and their corresponding signal strengths, especially the cardiotoxicity of anthracyclines, which is of great value for improving the clinical safety of anthracyclines."

Adverse events • Journal • Real-world evidence • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

From signal to significance: characterizing anthracycline-related hypercoagulable adverse events via pharmacovigilance, animal models, and clinical observation. (PubMed, Front Pharmacol) - "Doxorubicin was associated with the widest range of reported HC-AEs, whereas daunorubicin and aclarubicin showed more specific reporting patterns involving cerebral or intracardiac thrombosis and disseminated intravascular coagulation, respectively. This multi-database pharmacovigilance analysis provides a systematic overview of HC-AEs reported in association with anthracyclines, highlighting drug-specific reporting patterns and variations in onset timing across age groups. While causal inference cannot be established, the concordant signals observed across independent data sources support heightened clinical awareness and hypothesis-driven surveillance of thrombotic complications during anthracycline therapy."

Adverse events • Journal • Preclinical • Cardiovascular • Hematological Disorders • Oncology • Thrombosis

Role of Endogenous Myoglobin in Anthracycline Response in Breast Cancer. (PubMed, Biomolecules) - "Anthracyclines such as doxorubicin (DOX) remain central components of breast cancer (BC) chemotherapy, although their efficacy is frequently limited by drug resistance...In contrast, aclarubicin, an anthracycline lacking the hydroquinone moiety required for efficient redox cycling, failed to reproduce MB-dependent effects. Analyses of four independent neoadjuvant BC cohorts further demonstrated that elevated MB expression was consistently associated with reduced probability of achieving pathological complete response following anthracycline-containing chemotherapy. Collectively, these findings identify MB as a previously unrecognized modulator of BC response to redox-active anthracyclines and support its potential utility as both a predictive biomarker and therapeutic target."

Journal • Breast Cancer • Oncology • Solid Tumor • MB

Comparing the Efficacy of LDA, LHAA, and LA Regimens in Young Adults With Intermediate- and High-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy (clinicaltrials.gov) - P2/3 | N=450 | Enrolling by invitation | Sponsor: First Affiliated Hospital of Zhejiang University

New P2/3 trial • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy (clinicaltrials.gov) - P2/3 | N=267 | Enrolling by invitation | Sponsor: First Affiliated Hospital of Zhejiang University

New P2/3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

DISCOVERY AND VALIDATION OF A ROBUST 11-GENE PROGNOSTIC SIGNATURE VIA INTEGRATIVE MULTI-OMICS PROFILING IN VD-CAG-TREATED NON-M3 AML (EHA 2026) - "While the venetoclax-based VD-CAG regimen (venetoclax, decitabine, cytarabine, aclarubicin, granulocyte colony-stimulating factor) demonstrates promising efficacy, the underlying molecular response mechanisms and prognostic biomarkers remain poorly understood. Summary/Conclusion This study unveils specific molecular alterations related to the VD-CAG response and offers a validated 11-gene prognostic signature for non-M3 AML. These findings enhance the understanding of molecular response mechanisms and provide a potential tool for improved prognostic stratification."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • DOCK1 • IGF2BP3 • TLN1 • TMEM200A

VENETOCLAX-AZACITIDINE IN COMBINATION WITH CHIDAMIDE AND CAG VERSUS "3+7" REGIMEN IN FIT OLDER PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA:A MULTICENTER, RANDOMIZED, PHASE 3 TRIAL (EHA 2026) - "Aims This phase 3 trial aimed to evaluate the outcomes of a novel combined venetoclax-based (venetoclax-azacitidine combined with chidamide) and anthracyclines-based (aclarubicin and cytarabine) induction regimen (CACAG+VEN) versus "3+7" regimen in fit older patients aged 60-75 years with newly diagnosed AML. At a median follow-up of 12 months, the overall survival rate was 75% in the experimental group and 67% in the "3+7" group, with no statistically significant difference. . Summary/Conclusion In conclusion, the venetoclax - combined CACAG regimen exhibits favorable efficacy and safety in fit elderly patients with newly diagnosed AML."

Clinical • Combination therapy • P3 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Thrombocytopenia

VENETOCLAX-AZACITIDINE-CHIDAMIDE PLUS CAG AS INDUCTION CHEMOTHERAPY FOR MYELODYSPLASIA-RELATED ACUTE MYELOID LEUKEMIA (EHA 2026) - "Methods We included 14–75-year-old AML-MR patients (n = 29) treated with CACAG-VEN (aclarubicin, azacitidine, cytarabine, chidamide, and venetoclax plus G-CSF) between December 1, 2022 and October 31, 2024 and compared this cohort with patients (n = 39) who received the standard "3+7" regimen (daunorubicin plus cytarabine) from January 1, 2011 to January 31, 2020. The outcomes in the "3+7" group were inferior to those of patients who received the CACAG-VEN regimen (ORR: 71.8%, p = 0.009; CRc: 51.9%, p < 0.001; 1-year OS: 70.3%, p = 0.049). Summary/Conclusion The CACAG-VEN regimen is a potential frontline therapy for AML-MR, yielding superior response rates and longer survival durations than the standard "3+7" chemotherapy"

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Pneumonia • Respiratory Diseases • Septic Shock

EFFICACY AND SAFETY OF VENETOCLAX COMBINED WITH CAG REGIMEN AS INDUCTION THERAPY IN ELDERLY PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA: A MULTICENTER PHASE II STUDY (EHA 2026) - "This phase II, single-arm study aimed to evaluate the efficacy and safety of venetoclax combined with the CAG regimen (cytarabine, aclarubicin, and G-CSF) as induction therapy in elderly AML patients. Although infectious complications were frequent, the overall safety profile was acceptable and manageable. This regimen may represent an effective induction option for elderly AML patients, warranting further investigation in larger prospective studies."

Clinical • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Pneumonia • Respiratory Diseases • Septic Shock

Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Chinese PLA General Hospital | Trial primary completion date: Dec 2027 ➔ Sep 2027

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

Venetoclax, azacitidine, and chidamide in combination with cytarabine, aclarubicin, and G-CSF as induction chemotherapy for myelodysplasia-related acute myeloid leukemia. (PubMed, Clin Exp Med) - "And compared this cohort with patients (n = 30) who received the standard "3 + 7" regimen (daunorubicin plus cytarabine) from January 1, 2018 to December 31, 2022. The outcomes in the "3 + 7" group were inferior to those of patients who received the CACAG-VEN regimen (CR: 55.7%, p = 0.003; CRc: 56.4%, p = 0.005; 1-year OS: 73.3%, p = 0.039). The CACAG-VEN regimen is a potential frontline therapy for AML-MR, yielding superior response rates and longer survival durations than the standard "3 + 7" chemotherapy."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

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 | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Comparison of the efficacy and safety of venetoclax plus azacitidine versus decitabine combined with CAG regimen in the treatment of elderly patients with relapsed or refractory acute myeloid leukemia (ChiCTR) - P4 | N=50 | Completed | Sponsor: Shanghai Jing’an District Beizhan Hospital, Shanghai; Shanghai Jing’an District Beizhan Hospital

New P4 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

PD1-VEN-CAG: PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL (clinicaltrials.gov) - P3 | N=40 | Active, not recruiting | Sponsor: Fujian Medical University Union Hospital

New P3 trial • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • BCL2

Comparison of the efficacy and safety of venetoclax plus azacitidine versus D-CAG regimen in the treatment of elderly patients with relapsed or refractory acute myeloid leukemia (PubMed, Zhonghua Xue Ye Xue Za Zhi) - "Objective: To compare the efficacy and safety of venetoclax (VEN) combined with azacitidine (AZA) (VA) versus decitabine combined with cytarabine+aclarubicin+granulocyte colony-stimulating factor (CAG) (D-CAG) regimen in the treatment of elderly patients with relapsed or refractory acute myeloid leukemia (RR-AML) . The VA and D-CAG regimens have comparable efficacy for elderly patients with RR-AML. Patients with late relapse demonstrated better efficacy with both regimens compared with the early relapse and refractory groups."

Clinical • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=37 | Not yet recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

New P1/2 trial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T-Cell Lymphoma (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

New P2 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Chinese PLA General Hospital

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

Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Chinese PLA General Hospital | Trial completion date: Jan 2026 ➔ Jan 2030 | Trial primary completion date: Jan 2026 ➔ Jan 2029

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

Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=112 | Not yet recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • IDH1 • IDH2

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Chinese PLA General Hospital | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2026 ➔ Sep 2025

Enrollment closed • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology