A Randomized Phase III Study Evaluating A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Datos básicos

Código:
SEVENAZA
Protocolo:
SEVENAZA
EUDRACT:
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
406.419,00 €
Año de incio:
2024
Año de finalización:
2026
PI BIOMÉDICA NACIONAL Finan. Competitiva Privada

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FUNDACIÓN CRIS DE INVESTIGACIÓN PARA VENCER EL CÁNCER

Resultados del Ensayo Clínico


A Cutting-Edge Bioinformatics Tool for Neoantigen Identification in Unpaired RNA-Seq Samples of AML

Perez Miguez, Carlos; (...); Montesinos, Pau

Meeting Abstract. 10.1182/blood-2024-201407. 2024


A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 (Lacutoclax) As Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Burgues, Juan Miguel Bergua; (...); Curran, Emily K.

Meeting Abstract. 10.1182/blood-2024-208792. 2024


A phase 1b/2 study of pivekimab sunirine (PVEK, IMGN632) in combination with venetoclax/azacitidine for patients with newly diagnosed CD123-positive acute myeloid leukemia.

Daver, Naval Guastad; (...); Sallman, David Andrew

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.TPS6585. 2024

  • Open Access.

A phase 2, multicenter, clinical trial of CPX-351 in older patients with secondary or high-risk acute myeloid leukemia: PETHEMA-LAMVYX.

Rodríguez-Arbolí E; (...); Montesinos P

Article. 10.1002/cncr.35618. 2024

  • Open Access.

A systematic review of venetoclax for the treatment of unfit AML patients in real-world: is all that glitters gold?

Solana-Altabella A; (...); Montesinos P

Article. 10.1007/s00277-024-05891-w. 2024

  • Open Access.

AN INTERIM ANALYSIS OF FOVOCIP: A MULTICENTER RANDOMIZED TRIAL OF FOSFOMYCIN VERSUS CIPROFLOXACIN FOR FEBRILE NEUTROPENIA PREVENTION IN HEMATOLOGIC PATIENTS

Fernandez Moreno, Ahinoa; (...); Bernal, Teresa

Meeting Abstract. 2024


Autologous or allogeneic hematopoietic stem cell transplantation as front-line treatment for adult secondary acute myeloid leukemia patients: the PETHEMA registry experience.

Serrano, Josefina; (...); Montesinos, Pau

Article. 10.1016/j.jtct.2025.02.011. 2025


Contribution of copy number to improve risk stratification of adult T-cell acute lymphoblastic leukemia patients enrolled in measurable residual disease-oriented trials.

Gonzalez-Gil C; (...); Genesca E

Article. 10.3324/haematol.2024.285416. 2024

  • Open Access.

Do NPM1 and FLT3-ITD mutations modify prognosis in patients treated with non-intensive regimens?

Suárez EU; (...); Montesinos P

Article. 10.1007/s00277-024-05840-7. 2024


Engaging Innate Immunity By AFM28, an Innate Cell Engager (ICE®) Targeting CD123-Positive Leukemic Cells in Patients with Relapsed/Refractory Acute Myeloid Leukemia: Safety and Efficacy Results of a First-in-Human Phase 1 Study

Montesinos, Pau; (...); Recher, Christian

Meeting Abstract. 10.1182/blood-2024-194356. 2024


Evolving patterns and clinical outcome of genetic studies performed at diagnosis in acute myeloid leukemia patients: Real life data from the PETHEMA Registry.

Labrador, Jorge; (...); Montesinos, Pau

Article. 10.1002/cncr.35431. 2024

  • Open Access.

FITNESS ASSESSMENT IN ACUTE MYELOID LEUKEMIA: RECOMMENDATIONS FROM AN EXPERT PANEL ON BEHALF OF EUROPEAN LEUKEMIA NET.

Venditti, Adriano; (...); Ossenkoppele, Gert J

Article. 10.1182/bloodadvances.2024013744. 2025


Iadademstat in combination with azacitidine in patients with newly diagnosed acute myeloid leukaemia (ALICE): an open-label, phase 2a dose-finding study.

Salamero, Olga; (...); Montesinos, Pau

Article. 10.1016/S2352-3026(24)00132-7. 2024


In-depth analysis of responders in the phase 3 PhALLCON trial of ponatinib vs imatinib in newly diagnosed Ph plus ALL.

Jabbour, Elias; (...); Ribera-Santasusana, Jose-Maria

Meeting Abstract. https://doi.org/10.1200/JCO.2024.42.16_suppl.6533. 2024

  • Open Access.

In-depth Responder Analysis of PhALLCON, a Phase 3 Trial of Ponatinib Versus Imatinib in Newly Diagnosed Ph plus ALL

Jabbour, Elias; (...); Ribera-Santasusana, Jose-Maria

Meeting Abstract. 10.1016/S2152-2650(24)00426-9. 2024


Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study.

Zeidner, Joshua F; (...); Vyas, Paresh

Article. 10.1182/blood.2024027408. 2025


Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial

Cortes, Jorge E.; (...); Olutasidenib Combination Therapy Study Grp

Article. 10.1186/s13045-024-01657-z. 2025

  • Open Access.

Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML).

Cortes J; (...); Watts JM

Article. 10.1080/10428194.2024.2333451. 2024

  • Open Access.

Patient-reported Outcomes in Adults With Newly Diagnosed Ph plus Acute Lymphoblastic Leukemia Treated With Ponatinib or Imatinib in Combination With Reduced-Intensity Chemotherapy: Results From the Phase III PhALLCON Study

Ashaye, Ajibade; (...); Guo, Shien

Meeting Abstract. 2024


Ponalfil trial for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia: Long-term results.

Ribera, Josep-Maria; (...); Garcia-Sanz, Ramon

Article. 10.1002/hem3.67. 2024

  • Open Access.

Ponatinib vs Imatinib in Frontline Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial.

Jabbour, Elias; (...); Ribera, Jose-Maria

Article. 10.1001/jama.2024.4783. 2024

  • Open Access.

QuANTUM-First Trial: FMS-like Tyrosine Kinase 3-Internal Tandem Duplication (FLT3-ITD)-Specific Measurable Residual Disease (MRD) Clearance Assessed Through Induction and Consolidation Is Associated with Improved Overall Survival (OS) in Newly Diagnosed (ND) FLT3-ITD+ AML Patients

Perl, Alexander E.; (...); Levis, Mark J.

Meeting Abstract. 2024


QuANTUM-First: Efficacy by Age in Newly Diagnosed (nd) Patients With FMS-Like Tyrosine Kinase 3-Internal Tandem Duplication-Positive (FLT3-ITD+) Acute Myeloid Leukemia (AML)

Erba, Harry P.; (...); Montesinos, Pau

Meeting Abstract. 2024

  • Open Access.

Relapse Prevention in Acute Myeloid Leukemia: The Role of Immunotherapy with Histamine Dihydrochloride and Low-Dose Interleukin-2.

Montesinos, Pau; (...); Heuser, Michael

Article. 10.3390/cancers16101824. 2024

  • Open Access.

Salvage Therapy with Second-Generation Inhibitors for FLT3 Mutated Acute Myeloid Leukemia: A Real-World Study by the CETLAM and PETHEMA Groups

Vives, Susana; (...); PETHEMA Grp

Article. 10.3390/cancers16234028. 2024

  • Open Access.

Similar Outcome of Adolescents and Young Adults (AYA) and Older Adults with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) without Philadelphia Chromosome (Ph-) Included in the Pethema LAL-2019 Trial

Torrent, Anna; (...); Ribera, Josep-Maria

Meeting Abstract. 10.1182/blood-2024-207954. 2024


Somatic gene mutation patterns and burden influence outcomes with enasidenib in relapsed/refractory IDH2-mutated AML.

Risueno, Alberto; (...); Hasan, Maroof

Article. 10.1016/j.leukres.2024.107497. 2024

  • Open Access.

Superior Live Birth Rates, Reducing Sperm DNA Fragmentation (SDF), and Lowering Miscarriage Rates by Using Testicular Sperm Versus Ejaculates in Intracytoplasmic Sperm Injection (ICSI) Cycles from Couples with High SDF: A Systematic Review and Meta-Analysis

Cano-Extremera, Marina; (...); Puchalt, Nicolas Garrido

Review. 10.3390/biology14020130. 2025


Targeting CD38 with isatuximab and a novel CD38/CD3×CD28 trispecific T-cell engager in older patients with acute myeloid leukemia.

Martín-Sánchez E; (...); Zabaleta A

Article. 10.1182/bloodadvances.2024013212. 2024

  • Open Access.

Treatment patterns and outcomes in secondary acute myeloid leukemia arising after hypomethylating agents: PETHEMA registry study.

Lloret-Madrid, Pilar; (...); Montesinos, Pau

Article. 10.1002/cncr.35696. 2025


Validation of mutated CEBPA bZIP as a distinct prognosis entity in acute myeloid leukemia: a study by the Spanish PETHEMA registry.

De la Torre EP; (...); Montesinos P

Letter. 10.3324/haematol.2023.284601. 2024

  • Open Access.

Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): a multicentre, open-label, multi-cohort, phase 1 trial.

Wang ES; (...); Fathi AT

Article. 10.1016/S1470-2045(24)00386-3. 2024


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