azacitidine / Generic mfg. - LARVOL DELTA

SGNS70-101: A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies (clinicaltrials.gov) - P1 | N=178 | Recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: Jun 2027 ➔ Jun 2028 | Trial primary completion date: Jun 2026 ➔ Jun 2027

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

Cord Blood Transplantation in Relapsed/Refractory Pediatric Acute Myeloid Leukemia (AML) (ASPHO 2025) - "Due to residual disease after induction I, she received a 2nd induction cycle with fludarabine, cytarabine, and gemtuzumab. Then, she received a 3rd cycle with venetoclax and azacitidine. Due to persistent disease, she received CPX-351 with gilteritinib due to newly detected FLT3-ITD (allelic frequency 0.047)...After 4 cycles of menin inhibitor and a brief course of hydroxyurea and dexamethasone, with reduced but persistent disease burden, she underwent an unrelated 6/8 (A, DRB1 mismatched) CBT following conditioning with clofarabine, fludarabine, and busulfan... Unrelated CBT can induce remission in patients with otherwise refractory disease, and potentially induce long-term disease control. This case represents the need for more research for a potential maintenance treatment regimen including single agent menin inhibitor for high risk patients with refractory disease post-CBT."

Clinical • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Pediatrics • Transplantation • HLA-DRB1 • NSD1 • NUP98

Cardiac, Renal, and Skin Myeloid Sarcomas and Differences in Response to Chemotherapy: A Case Report (ASPHO 2025) - "Flow cytometry confirmed the diagnosis of AML and induction I per AAML1831 with etoposide added was initiated...It demonstrated transient improvement [1.6x1x1.5cm] on day 12 of cycle two chemotherapy with fludarabine, cytarabine, dexrazoxane, idarubicin, and venetoclax...On day four of cycle three, consisting of venetoclax, azacytidine, and gemtuzumab ozogamicin, the patient developed multiple erythematous, indurated nodules consistent with leukemia cutis, confirmed by biopsy... Our patient with AML presented with chloromas in multiple sites, heart, kidney, and skin, which had different responses to chemotherapy regimens. The initial cardiac chloroma resolved with standard chemotherapy and has not recurred. The patient also developed leukemia cutis in cycle three of therapy."

Case report • Clinical • Acute Myelogenous Leukemia • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Sarcoma • Solid Tumor • Thrombocytopenia

Sweet Syndrome in two Pediatric Patients: A Bitter Reminder to Check for Underlying Malignancy (ASPHO 2025) - "His disease rapidly progressed to MDS with excess blasts; thus, he was treated with induction cytotoxic chemotherapy followed by azacitidine and proceeded to hematologic stem cell transplantation after achieving complete remission... SS/HSS is rare in pediatric patients; however, similar to adult patients, there is a strong association with underlying malignancy. Pediatric patients with SS/HSS should have a thorough evaluation for associated etiologies such as assessment of current medications, testing for infections, and referral to oncologists for bone marrow evaluation. The rapid progression of the first patient's MDS is atypical of MDS with del(5q), a usually indolent syndrome in adults."

Clinical • Atopic Dermatitis • Dermatology • Fatigue • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Oncology • Pain • Pediatrics • CD34 • FLT3 • PTPN11

Synchronous Mediastinal Germ Cell Tumor With Sarcomatous Transformation and Acute Myeloid Leukemia (ASPHO 2025) - "He received three cycles of ifosfamide and doxorubicin (per COG ARST0332 Arm D) followed by surgical resection, with normalizing AFP levels...Leukemia treatment was initiated with cladribine, idarubicin, cytarabine and venetoclax (CLIA+Ven)...Intensification 1 with cytarabine and etoposide per AAML1831/0531 was followed by conditioning with busulfan, thiotepa, fludarabine and post-transplant cyclophosphamide and haploidentical stem cell transplant (SCT) from his sister...Despite salvage therapy with azacitidine and venetoclax, he succumbed to his disease without achieving remission... While somatic malignant transformation and an association with AMKL are known in GCTs, it is unusual that our patient had GCT, angiosarcoma, and AKML simultaneously. Furthermore, transformation to angiosarcoma is extremely rare. In this patient, acute megakaryoblastic leukemia (AMKL) was diagnosed from review of a marrow done prior to treatment."

Acute Myelogenous Leukemia • Anemia • Angiosarcoma • Germ Cell Tumors • Hematological Disorders • Hematological Malignancies • Leukemia • Musculoskeletal Pain • Oncology • Pain • Pediatrics • Sarcoma • Solid Tumor • Thrombocytopenia • AFP • PTEN • TP53

A Machine Learning-Based Strategy Predicts Selective and Synergistic Drug Combinations for Relapsed Acute Myeloid Leukemia. (PubMed, Cancer Res) - "In preliminary experiments on clinical trial samples, the approach predicted clinical outcomes to venetoclax-azacitidine combination therapy in patients with AML. Overall, the computational-experimental approach provides a rational means to identify personalized combinatorial regimens for individual AML patients with R/R disease that target treatment-resistant leukemic cells, thereby increasing their likelihood for clinical translation."

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

Venetoclax + Azacitidine vs. Induction Chemotherapy in AML (clinicaltrials.gov) - P2 | N=172 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Jan 2026 ➔ Jan 2028 | Trial primary completion date: Jan 2025 ➔ Jan 2027

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • BCL2

RAINIER: APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Aptevo Therapeutics | Not yet recruiting ➔ Recruiting

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

Azacitidine plus venetoclax for maintenance treatment in intermediate‑to‑low‑risk acute myeloid leukemia: A comparative analysis of clinical outcomes in an observational cohort. (PubMed, Oncol Lett) - "After adjusting for confounding factors, multivariate Cox proportional hazards model showed that maintenance treatment was associated with a reduced risk of relapse and a longer PFS time, compared with discontinued treatment (hazard ratio, 0.06; 95% confidence interval, 0-0.77). Therefore, patients treated with VEN-AZA exhibited a longer PFS time, suggesting that further clinical trials are warranted."

Clinical data • Journal • Observational data • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Neutropenia • Respiratory Diseases • Thrombocytopenia

γ9δ2 T-cell activation (γδTCA) with ICT01 combined with azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT04243499 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P1/2 data • Acute Myelogenous Leukemia

In Vitro Drug Profiling to Guide Treatment for Relapse/Refractory AML (ASH 2024) - "Significant correlation was observed among drugs of the same classes, for example between inhibitors of PARP (e.g. niraparib-talazoparib, r=0.78, p=1.3e-22), proteasome (e.g. bortezomib-ixazomib, r=0.90, p=4.2e-36), JAK (ruxolitinib-tofacitinib, r=0.91, p=8.3e-35), MEK (cobimetinib-trametinib, p=0.93, p=8.8e-47) and CDK (abemaciclib-palbociclib, p=0.56, p=2.7e-10), confirming that the readout is biologically meaningful. Intriguingly, there were unexpected correlations between specific pairs of drugs of different classes, for instance homoharringtonine (protein translation inhibitor)-abemaciclib (CDK inhibitor) (r=0.65, p=4.3e-17) and between specific gene mutations and drug sensitivity was observed, e.g. sensitivity of CEBPAbZIP mutated samples to PARP inhibitors (p=0.00156), and of AML with inv(16) to MEK inhibitors (p=0.0016)...Drug response to daunorubicin showed good prediction of chemo-resistance in patients who had non-remission after "7+3" (ROC curve AUC..."

Preclinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • ANXA5 • FLT3

Venetoclax/azacitidine vs intensive chemotherapy as a bridge to allogeneic HSCT in AML: Experience from Ukraine. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Acute Myelogenous Leukemia • Bone Marrow Transplantation

Treatment Patterns and Real-World Outcomes of Molecular Subgroups in Patients With AML Receiving Frontline Venetoclax-Based Therapy. (PubMed, JCO Oncol Pract) - "The median rwOS for this study was comparable with results in the VIALE-A trial, despite the community-based nature of these data. There was no clear standard of care for patients who received 2L+ therapy. These data highlight the need for novel treatment for patients with AML following 1L VEN-based therapy."

Journal • Real-world evidence • Acute Myelogenous Leukemia • FLT3 • IDH1 • IDH2 • NPM1

Efficacy Prediction of Platelet Count Trajectories after Induction Therapy with Venetoclax Combined with Azacitidine in Newly Diagnosed AML Patients (PubMed, Zhongguo Shi Yan Xue Ye Xue Za Zhi) - "The dynamic trajectory of platelet counts in newly diagnosed AML patients who received VA treatment can serve as a significant indicator to observe the efficacy and prognosis. The platelet rapidly increased is an independent protective factor for good prognosis. TheIDH1 /2 mutation and platelet transfusion are independent influencing factors of platelet trajectory."

Journal • Retrospective data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • IDH1 • IDH2

Successful treatment of multi-hit TP53-mutated myelodysplastic syndromes with erythroid predominance using allogeneic stem cell transplantation and ruxolitinib. (PubMed, Ann Hematol) - "The patient exhibited chemoresistance to multiple regimens, including cytarabine with daunorubicin, high-dose cytarabine, and venetoclax with azacitidine. This case highlights the potential of combining graft-versus-leukemia effects with ruxolitinib as a therapeutic strategy for TP53-mutated MDS/AEL. Further studies are warranted to evaluate the efficacy and safety of this strategy in a broader clinical setting."

Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • TP53

Daratumumab, Venetoclax, and Azacitidine in Combination with HAA Regimen as Consolidation Chemotherapy for T-cell Acute Lymphoblastic Leukemia with High CD38 Expression. (PubMed, Turk J Haematol) - No abstract available

IO biomarker • Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD38

Phase II study of cladribine, low-dose cytarabine, and venetoclax, alternating with azacitidine and venetoclax, in higher-risk chronic myelomonocytic leukemia and myelodysplastic syndromes. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05365035 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

P2 data • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Invasive Aspergillosis Laryngitis Causing a Difficult Intubation (ATS 2025) - "Limited data is available on treatment strategies given the rarity of the disease, but patients typically respond well to typical antifungals, with surgery rarely being needed.Case PresentationThe patient presented here is a 56-year-old woman with acute myeloid leukemia on chemotherapy with azacitidine and venetoclax presented to the emergency department with complaints of hoarseness of voice and dyspnea for two weeks...Arterial blood gas while on High flow nasal cannula 60 liters, 60% was significant for pH of 7.10, pCO2 of 68, and PO2 of of 76, consistent with acute hypoxemic and hypercapnic respiratory failure.The patient was placed under moderate sedation with Midazolam and Fentanyl...The biopsy cultures grew Aspergillus fumigatus, and treatment was initiated with Amphotericin B. The patient was extubated on day five of intubation and, after finishing her fourteen-day course of Amphotericin, was discharged on Isavuconazonium with infectious disease outpatient..."

Intubation • Acute Myelogenous Leukemia • Anesthesia • Dysphonia • Hematological Malignancies • Infectious Disease • Laryngeal Cancer • Leukemia • Oncology • Otorhinolaryngology • Pulmonary Disease • Rare Diseases • Respiratory Diseases

Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: University of Colorado, Denver | Trial primary completion date: Jun 2026 ➔ Apr 2025

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

Combining annamycin, a non-cardiotoxic potent topo II poison, with azacitidine, cytarabine, gemcitabine, ifosfamide, trabectedin, or vincristine to synergize anticancer effects and identify potential clinical applications (AACR 2025) - "Background: Annamycin (ANN) is a potent topoisomerase II poison structurally related to doxorubicin (DOX) but displaying superior biological properties, such as high in vivo efficacy, reduced toxic side effects, and activity against cancers resistant to common therapeutic agents...The most efficacious drug combinations from the in vitro studies were then tested using in vivo models of leukemia and solid tumors, including sarcoma and pancreatic cancer. The in vitro screening performed in set of cancer cell lines led to selection of the following agents combined with ANN for testing efficacy in clinically relevant animal models: 1) Cytarabine, 2) Azacitidine, 3) Venetoclax, 4) Vincristine in AML model; 5) Ifosfamide in fibrosarcoma; 6) Irinotecan and 7) Gemcitabine in PATC53 pancreatic cancer model... ANN appears to be a versatile drug forming efficacious combinations with numerous mechanistically different anticancer agents. Our studies are working toward identifying new..."

Clinical • Fibrosarcoma • Hematological Malignancies • Leukemia • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

Comparative safety and effectiveness of azacitidine plus venetoclax versus intensive chemotherapy in acute myeloid leukemia: A propensity score-matched analysis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

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

Outcomes for adults with KMT2A-r acute myeloid leukemia treated with venetoclax plus azacitidine (Ven/Aza) or intensive chemotherapy (IC): A single-center retrospective study. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Retrospective data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A

Successful Complete Remission with Chidamide, Venetoclax, and Azacytidine in Relapsed Acute Myeloid Leukaemia Associated with Plasmacytoid Dendritic Cells. (PubMed, J Coll Physicians Surg Pak) - "Null."

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

Venetoclax-Azacitidine Salvage Chemotherapy in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome: A Single-Center Experience. (PubMed, J Hematol) - No abstract available

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

AARON: An ongoing open-label phase I/II study of relatlimab (anti-LAG-3) with nivolumab (anti-PD-1) in combination with azacitidine ± venetoclax for the treatment of patients with relapsed/refractory and non-fit patients with newly diagnosed acute myeloid leukemia - Interim analysis (AACR 2025) - P2 | "We continue to enroll non-fit frontline patients. The ongoing comprehensive immunomonitoring program aims to elucidate mechanisms of treatment response."

Clinical • Combination therapy • IO biomarker • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IFNG • NPM1