A phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib (IVO) monotherapy and azacitidine (AZA) monotherapy in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation (PyramIDH study).
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Leucemia mieloide aguda, Síndromes mielodisplásicos, Linfoma
FECHA DE APERTURA
Diciembre, 2024
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to World Health Organization (WHO) criteria (5th edition): - Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%. - Low and moderate low-risk MDS per IPSS-M score must: o Have cytopenias related to MDS, defined as: <100 platelets/L, or absolute neutrophil count (ANC) <1000/mm3, or Hgb <10g/dL AND o Have a blast count between 5-19% AND o Be eligible for HMA therapy (very low risk participants are to be excluded).
Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation.
Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation.
CRITERIOS DE EXCLUSIÓN
Received prior anticancer/disease modifying treatment for MDS (including HMAs, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.
> 20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate.
> 20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate.
DESCRIPCIÓN
To assess the efficacy of IVO monotherapy in participants with HMA naive MDS with an IDH1m
PALABRAS CLAVE
idh1, leucemia linfocítica crónica (llc / cll), mds, myelodysplastic syndrome
