aclarubicin / Generic mfg. - LARVOL DELTA

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

Diagnosis and management of rare acute erythroid leukemia with hemophagocytic lymphohistiocytosis: a case report. (PubMed, Front Oncol) - "Initial therapy with a decitabine-CAG (aclacinomycin, cytarabine, G-CSF)-venetoclax regimen failed to induce remission. Morphological complete remission was achieved after switching to a DAE (daunorubicin, cytarabine, etoposide) regimen...This case highlights the diagnostic and therapeutic complexities associated with the co-occurrence of AEL and HLH. Early identification of HLH as a potential complication in AEL is crucial, though outcomes remain dismal, emphasizing an urgent need for novel therapeutic strategies."

Journal • Bone Marrow Transplantation • Fatigue • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Oncology • Rare Diseases • Respiratory Diseases • Transplantation • CRP

Venetoclax and azacitidine versus CAG for unfit patients with newly diagnosed acute myeloid leukemia: A propensity score-matched analysis. (PubMed, Leuk Res) - "This study evaluated the clinical efficacy of venetoclax and azacitidine (VEN+AZA) versus CAG (cytarabine, aclarubicin, and granulocyte colony-stimulating factor) for newly diagnosed adult acute myeloid leukemia (AML) unfit patients. 31.7 % (P = 0.20). Patients with age ≥ 60 y (EFS, P = 0.032), ECOG≥ 2 (EFS, P = 0.047), secondary AML (OS, P = 0.015; EFS, P = 0.039), ELN intermediate-adverse karyotype (OS, P = 0.034; EFS, P = 0.044), RUNX1 mutation (OS, P = 0.003; EFS, P = 0.003) and IDH1/2 mutation (EFS, P = 0.039) showed a preference for VEN+AZA regarding OS, and patients with SRSF2 mutation favored CAG in OS (P = 0.031)."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • DNMT3A • IDH1 • IDH2 • RUNX1 • RUNX1T1 • SRSF2

S2023-056-01: Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: Chinese PLA General Hospital | Recruiting ➔ Completed

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

Phase 1 study of chidamide in combination with venetoclax, azacitidine, aclarubicin, cytarabine and G-CSF for refractory/relapsed acute myeloid leukemia: clinical safety, efficacy, and correlative analysis. (PubMed, Front Immunol) - P1 | "In patients with R/R AML, the CACAG-VEN regimen resulted in significant clinical benefits, with a high CRc rate and encouraging survival, as well as being well tolerated. https://www.chictr.org.cn/, identifier, ChiCTR2200065634."

Clinical • Journal • P1 data • Acute Myelogenous Leukemia • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Neutropenia • Oncology • Thrombocytopenia • ABCC1 • BCL2 • HIF1A

In-class transition from bortezomib to ixazomib-based regimens in transplant-ineligible patients with newly diagnosed multiple myeloma: A retrospective, observational, real-world study conducted in China (ASH 2025) - "The most common V-based regimens included VRd (bortezomib, lenalidomide, dexamethasone, 48.6%), Vd (bortezomib, dexamethasone, 28.0%), VCd (bortezomib, cyclophosphamid, dexamethasone, 23.4%), VAd (bortezomib, Aclarubicin, dexamethasone, 11.2%), and others. This observational study involving transplant-ineligible NDMM patients in China indicates that switching from bortezomib to ixazomib-based regimens allows for extended continuous PI-based therapy, offering favorable efficacy, acceptable safety, and enhanced treatment convenience. Despite the presence of multiple comorbidities among the patient cohort, this therapeutic strategy may serve as a viable treatment option for individuals with transplant-ineligible NDMM."

Real-world • Real-world evidence • Retrospective data • Cardiovascular • CNS Disorders • Diabetes • Hematological Disorders • Hematological Malignancies • Hepatology • Hypertension • Metabolic Disorders • Multiple Myeloma • Nephrology • Renal Disease • Transplantation • Vascular Neurology

Venetoclax combined with cacag regimen as a bridge to allogeneic hematopoietic stem cell transplantation in patients with previously untreated acute myeloid leukemia achieving CR1 (ASH 2025) - "The CACAG regimen included: venetoclax (100 mg on day 1, 200 mg on day 2, 400 mg on days 3–14; dose reduced to 100 mg/day when combined with azoles), chidamide (30 mg on days 1 and 4), azacitidine (75 mg/m² on days 1–7), cytarabine (75–100 mg/m² every 12 hours on days 1–5), aclacinomycin (20 mg on days 1, 3, and 5), and recombinant human granulocyte colony-stimulating factor (rhG-CSF, 300 μg/day until neutrophil recovery). Compared to the historical cohort, venetoclax combined with CACAG reduced the incidence of aGVHD and demonstrated potential for improved relapse outcomes post-transplant."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Transplantation

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 • Febrile Neutropenia • 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

Treatment outcomes in patients with newly diagnosed multiple myeloma receiving ixazomib as initial therapy: A retrospective, observational, real-world historical database analysis from China (ASH 2025) - "About 65% of the patients had at least one comorbidity, withthe most common being hypertension (38%), renal disorders (35%), cardiovascular diseases (31%),diabetes (18%), and liver disorders (17%).Ixazomib-based regimens consisted of combinations such as Ixazomib plus IMiD with or without otheragents (e.g., IR[Ixazomib, lenalidomide], ITd[Ixazomib, thalidomide, dexamethasone], IPd[Ixazomib,pomalidomide, dexamethasone], IRAd[Ixazomib, lenalidomide, aclarubicin, dexamethasone],IRCd[Ixazomib, lenalidomide, cyclophosphamid, dexamethasone]) and Ixazomib plus dexamethasonewith or without additional agents (e.g., ICd[Ixazomib, cyclophosphamid, dexamethasone], IACd[Ixazomib,aclarubicin, cyclophosphamid, dexamethasone], Id + epirubicin, ICd + epirubicin , Id + denosumab,IMd[Ixazomib, melphalan, dexamethasone]). Survival outcomes remain under ongoing follow-up. Thesefindings suggest that ixazomib-based therapy may serve as a viable first-line treatment option, even forpatients..."

Real-world • Real-world evidence • Retrospective data • Cardiovascular • Diabetes • Hematological Malignancies • Hepatology • Hypertension • Metabolic Disorders • Multiple Myeloma • Nephrology • Renal Disease

Safety and efficacy of venetoclax plus CAG (cytarabine, aclarubicin, G-CSF) regimen in patients with relapsed or refractory Acute Myeloid Leukemia: A prospective single-arm phase II study (ASH 2025) - P2 | "The most common non-hematological AE was infection (23.5%).ConclusionThe venetoclax plus CAG regimen can serve as a safe and effective new option for salvage chemotherapyin patients with R/R AML. This combined regimen may help more patients to achieve the opportunity torecieve HSCT with a smaller tumor budern and improve the outcomes of patients."

Clinical • P2 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Febrile Neutropenia • Infectious Disease • Leukopenia • Neutropenia

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

Extensive myeloid sarcoma presenting with esophageal compression and dysphagia as the initial manifestation. (PubMed, Medicine (Baltimore)) - "Infiltrative mediastinal/retroperitoneal MS may present with esophageal obstruction and mimic lymphoma or carcinoma. High-index suspicion, targeted biopsy with high-power morphology, and a focused immunohistochemical panel are critical for timely diagnosis and treatment initiation."

Journal • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Sarcoma • Solid Tumor • CD2 • CD20 • CD34 • CD5 • CD7 • CD79A • CD99 • CK19 • KIT • KRT19 • PTPRC

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

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

Determining Preclinical Safety of Aclarubicin in Pediatric Malignancies. (PubMed, Pediatr Blood Cancer) - "Our study highlights Acla as a promising anthracycline derivative for pediatric cancers, with potent anti-tumor efficacy and a superior safety profile, even following prior anthracycline 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

Acute Myeloid Leukemia Patients with High-Risk Karyotypes Benefit from Decitabine in Combination with Modified CAG. (PubMed, Biochem Genet) - "This study aims to investigate the genetic characteristics of Acute Myeloid Leukemia (AML) patients and identify which patients derive the greatest benefit from a low-intensity regimen of decitabine combined with modified Cytarabine + Aclarubicin + Granulocyte Colony-Stimulating Factor (D-CAG) or intensive chemotherapy (IA regimen). Notably, older patients with complex or monosomal karyotypes exhibited longer median OS than their younger counterparts (P < 0.05). In conclusion, D-CAG may represent a more suitable therapeutic option for AML patients with high-risk karyotypic profiles."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Neuroblastoma • Oncology • Solid Tumor • Transplantation • CEBPA • NRAS • TET2

Venetoclax plus decitabine, cytarabine, aclarubicin, and G-CSF in adults with newly diagnosed acute myeloid leukemia: A multicenter, retrospective study. (PubMed, Int J Cancer) - "The VD-CAG regimen represents an effective induction therapy for young ND-AML. It leads to high rates of CRc and MRD-negative remissions, along with encouraging OS and EFS across prognostic subgroups."

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

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