aclarubicin / Generic mfg. - LARVOL DELTA

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 Disorders • Hematological Malignancies • Leukemia • Oncology • ENG

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

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

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

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

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 Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Septic Shock • FLT3 • TP53

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

Single-Center Retrospective Clinical Evaluation of 7-Day Venetoclax Combined with Decitabine and CAG Regimen for AML Older Than 60 Years (ASH 2024) - "Our retrospective analysis found that the 7-day short-term venetoclax combiend with decitabine and CAG (G-CSF priming, low dose cytarabine and aclarubincin ) induction chemotherapy induced higher remission rates and higher MRD-negativity rates compared with the venetoclax plus azacitidine (VA) regimen in in newly diagnosed AML patients older than 60 years...VD-CAG regimen was administered as follows : venetoclax orally once daily (100mg on day 1, 200mg on day 2, 400mg on days 3-9), decitabine 20 mg/m2 intravenously on days 1-5, cytarabine 10 mg/m2 subcutaneously q12h on days 3-9, aclacinomycin 10 mg/m2 intravenously on days 3-6, G-CSF 300 μg /d subcutaneously on days 0 -9. For patients with leukocytosis, hydroxyurea was given orally until the WBC count dropped below 10×10 9 /L, and then the chemotherapy was initiated...The therapy was able to induce deeper remission, and improve long-term survival rate, with a safety profile not significantly different from that of..."

Retrospective data • Acute Myelogenous Leukemia • Infectious Disease • Respiratory Diseases

Venetoclax Plus D-CAG (decitabine, cytarabine, aclarubicin, G-CSF) for Elderly or Unfit Patients with Newly Diagnosed Acute Myeloid Leukemia: A Multicenter, Prospective Study (ASH 2024) - "In addition, blood cell recovery was quick, with a median time to absolute neutrophil count ≥ 1.0×109/L and platelet count ≥ 100×109/L at 19 days and 15.5 days, respectively. Conclusions : VD-CAG demonstrates high efficacy as an induction treatment for elderly or unfit patients with newly diagnosed AML, and it could be an alternative upfront therapy for this subpopulation, Trials with large-scale subjects are needed for further validation, especially for secondary AML."

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

Evaluation of Lymphocyte Immunity in Patients Treated with Venetoclax-Azacitidine for Acute Myeloid Leukemia (ASH 2024) - "Ten patients received Ven-Aza (AML n=10) and 9 patients received Aza monotherapy (AML n=5 and MDS n=4), and 8 patients was administrated other regimens (AML n=5 and APL n=3) including IDA+Ara-C (n=2), CAG (Low dose Ara-C + aclarubicin + G-CSF, n=2), giltertinib (n=1) and ATRA+ATO (n=3). Given the limitations of this retrospective and small single-center study, further prospective studies with larger cohorts are needed to elucidate the impact of Ven-Aza on CD4+ T cell function and immune phenotype. The mechanism by which serum immunoglobulin level is intact despite severe B-cell reduction could be revealed as well in the larger and more detailed study."

Clinical • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • CD4 • CD8

How to Improve the Efficacy of Venetoclax and Azacitidine(VA)for Newly Diagnosed Acute Myeloid Leukemia?a Prospective, Single-Center, Single-Arm, Phase 2 Trial for New Diagnosed AML (ASH 2024) - P2 | "AML was diagnosed according to the 2016 WHO classification, Patients were treated with VA+HAAG regimen, which consists of venetoclax 100mg orally on days 1, 200mg orally on days 2, 400 mg orally on days 3--10, azacitidine 75mg/m2/d subcutaneous injection on days 1-7, homoharringtonine 1 mg/d intravenously on days 4- 10, aclarubicin 10 mg/d intravenously on days 4-7, cytarabine (Ara-C) 10 mg/m2 q12h subcutaneously on days 4-10, and granulocyte colony-stimulating factor (G-CSF) 50-300 µg/d subcutaneously on days 3-10. CONCLUSIONS : In conclusion, the VA combined with HAAG 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 adverse risk and FAB-M4/M5 subtype compared to the VA regimen."

Clinical • IO biomarker • P2 data • Acute Myelogenous Leukemia • B Cell Lymphoma • Bone Marrow Transplantation • Infectious Disease • Lymphoma • Neutropenia • Septic Shock • Thrombocytopenia • BCL2 • CBFB • CEBPA • DNMT3A • FLT3 • KMT2A • NPM1 • RUNX1 • RUNX1T1 • TP53

A Phase I Study of Chidamide in Combination with Dcag and Venetoclax in Acute Myeloid Leukemia: Clinical Safety, Efficacy, and Correlative Analysis (ASH 2024) - P2 | "Patients received induction treatment with intravenous aclarubicin (10mg/m²/d on day 1, 3, 5), subcutaneous azacitidine (75 mg/m² on day 1–7), intravenous cytarabine (75 mg/m2/bid on day 1-5), oral chidamide (30mg, twice/week for two week), and oral venetoclax (100 mg on day 1, 200 mg on day 2, 400 mg on day 3-14). Interpretation This study proposed the CACAG+VEN regimen as an efficacious induction therapy for newly diagnosed AML, attaining a high CRc rate, predominantly in NCCN adverse-risk patients. And it provided insights into the transcriptional dynamics of AML during treatment with the CACAG+VEN regimen."

Clinical • Combination therapy • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Gene Therapies • Hematological Malignancies • Leukemia • Oncology • ASXL1 • BCL2A1 • FLT3 • NPM1 • NRAS

Venetoclax with Hypomethylating Agents Compared with Priming Regimens for Newly Diagnosed Patients with Acute Myeloid Leukemia with Myelodysplasia Related Changes: A Single Center Retrospective Study (ASH 2024) - "Seventy patients received venetoclax plus hypomethylating agents (VEN+HMA) and 76 patients received priming regimens based on cytarabine(A), G-CSF(G) and idarubicin(I), aclarubicin(A) or homoharringtonine(H) with or without hypomethylating agents (IAG±HMA, AAG±HMA, HAG±HMA). Our data may help guide treatment decisions for ND AML-MR patients who are eligible candidates for both of VEN+HMA and priming regimens. Of course, a large prospective, multi-center, randomized study is needed to validate these findings."

Retrospective data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • ASXL1 • BCOR • RUNX1 • SF3B1 • SRSF2 • STAG2 • U2AF1 • ZRSR2