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    DRUG:

    azacitidine

    i
    Other names: U-18496, Aza-C, NS 17, NS-17, Aza C, NSC-102816
    Company:
    Generic mfg.
    Drug class:
    DNMT inhibitor
    Related drugs:
    1d
    Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML (clinicaltrials.gov)
    P=N/A, N=27, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Venclexta (venetoclax) • azacitidine • Duoenda (mitoxantrone liposomal)
    1d
    MP0533-CP101: Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1/2, N=249, Active, not recruiting, Molecular Partners AG | Recruiting --> Active, not recruiting | Trial completion date: Dec 2029 --> May 2027 | Trial primary completion date: Dec 2027 --> May 2026
    Enrollment closed • Trial completion date • Trial primary completion date • First-in-human
    |
    Venclexta (venetoclax) • azacitidine • Gazyva (obinutuzumab) • MP0533
    1d
    VA Induction and Bridging Transplantation for Hypoplastic/Secondary AML (clinicaltrials.gov)
    P=N/A, N=50, Not yet recruiting, The First Affiliated Hospital of Soochow University
    New trial
    |
    Venclexta (venetoclax) • azacitidine
    2d
    Early Transplantation After Pretransplant Reduction of TP53-Altered Clones and Prolonged Dose-Adjusted Azacitidine Maintenance: A Three-Case Series. (PubMed, EJHaem)
    Pretransplant treatment was intentionally limited to 2-3 cycles: three cycles of Aza in Case 1, intensive induction chemotherapy followed by one cycle of Aza in Case 2, and two cycles of venetoclax plus Aza in Case 3. In addition, for patients with FISH-detectable TP53 abnormalities, serial FISH may provide a practical adjunct for pretransplant decision-making in routine practice. Trial Registration: The authors have confirmed clinical trial registration is not needed for this submission.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    Venclexta (venetoclax) • azacitidine
    5d
    Venetoclax and Azacitidine for the Treatment of Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (clinicaltrials.gov)
    P1/2, N=34, Terminated, M.D. Anderson Cancer Center | Active, not recruiting --> Terminated; <75% participation
    Trial termination
    |
    Venclexta (venetoclax) • azacitidine
    7d
    EVICTION 3: A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and Venetoclax, Compared to Placebo in Combination With Azacitidine and Venetoclax, in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Intensive Chemotherapy (clinicaltrials.gov)
    P2/3, N=450, Not yet recruiting, Ipsen
    New P2/3 trial
    |
    Venclexta (venetoclax) • azacitidine • IPN60340
    8d
    Ziftomenib with venetoclax and azacitidine in relapsed/refractory NPM1-mutated acute myeloid leukemia. (PubMed, Blood)
    The combination of ziftomenib 600 mg with venetoclax/azacitidine was well tolerated with deep and durable clinical activity in R/R NPM1-m AML. This trial was registered at www.ClinicalTrials.gov as #NCT05735184.
    Journal
    |
    NPM1 (Nucleophosmin 1)
    |
    NPM1 mutation
    |
    Venclexta (venetoclax) • azacitidine • Komzifti (ziftomenib)
    9d
    Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy (clinicaltrials.gov)
    P2, N=60, Recruiting, Shirley Ryan AbilityLab | Not yet recruiting --> Recruiting
    Enrollment open
    |
    azacitidine
    10d
    A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL (2024-516570-30-00)
    P1/2, N=12, Not yet recruiting, Centre Hospitalier De Versailles
    New P1/2 trial
    |
    Venclexta (venetoclax) • everolimus • azacitidine • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • tofacitinib
    12d
    Dysregulated HELLS expression alters cellular processes and serves as a potential prognostic marker in acute myeloid leukemia. (PubMed, J Biol Chem)
    Furthermore, HELLS deficiency enhanced myeloid differentiation and apoptosis in HL-60 cells when treated with chemotherapy drugs, including 5-azacytidine, cytarabine, and doxorubicin. Ex vivo validation in AML patient-derived LSPCs demonstrated that HELLS deficiency reduces leukemic marker burden (CD123 and TIM-3) and increases apoptosis. Overall, we show HELLS upregulation drives leukemogenesis with poor outcomes, highlighting its potential as a prognostic marker and therapeutic target in AML.
    Journal • IO biomarker
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • SMARCA2 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily A, Member 2) • HELLS (Helicase, Lymphoid Specific)
    |
    cytarabine • doxorubicin hydrochloride • azacitidine
    12d
    tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy (clinicaltrials.gov)
    P2, N=80, Recruiting, Shirley Ryan AbilityLab | Not yet recruiting --> Recruiting
    Enrollment open
    |
    azacitidine
    12d
    Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=32 --> 17
    Enrollment closed • Enrollment change
    |
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • BCL2 (B-cell CLL/lymphoma 2) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • azacitidine • adrixetinib (Q702)