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One-year consolidation with Ponatinib 15 mg in chronic myeloid leukaemia on deep molecular response with Imatinib

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Pérez-Lamas, L.
  • Manzanares, M.
  • Hernández-Boluda, J.C.
  • Casado-Montero, L.F.
  • Gómez-Casares, M.T.
  • Ayala, R.
  • Xicoy-Cirici, B.
  • Ferrer-Marín, F.
  • Ortí, G.
  • de Paz, R.
  • Osorio-Prendes, S.
  • Pérez-López, R.
  • Ruiz-Nuño, C.
  • Jiménez-Velasco, A.
  • Boqué, C.
  • Sierra-Pacho, M.
  • Martínez-López, J.
  • Carreño-Tarragona, G.
  • Coiras, M.
  • García-Gutiérrez, V.

Grupos

Abstract

Tyrosine kinase inhibitors (TKIs) discontinuation is the standard option for patients with chronic myeloid leukaemia (CML) in deep molecular response (MR) with imatinib. This study aimed to evaluate the efficacy and safety of one year consolidation with ponatinib on treatment-free remission (TFR) rate. This was a multicenter open-label, single-arm, phase II, exploratory clinical trial including patients with CML treated =4 years with imatinib therapy, and MR4.0 =12 months. Patients entered the TFR phase after receiving ponatinib at 15 mg/day for one year. Twenty three patients received ponatinib and 19 completed consolidation. Among the patients with detectable BCR::ABL1, 70% deepened response. The 48-weeks MR4.0 rate was 68.4% (95%CI: 43.4-87.4). The 48-week TFR rate as classically defined was 73.7% (95% CI: 8 56.3-96.4). Five restarted TKIs and all regained MR. The most frequent adverse events (AEs) were constipation (34.8%), asthenia (30.4%) and myalgia (21.7%). Patients who remained relapse-free one year after ponatinib discontinuation exhibited higher levels of NK and NKT-like cells with degranulation capacity. Consolidation with ponatinib showed a high TFR rate and adequate safety, granting further research. © The Author(s) 2026.

Datos de la publicación

ISSN/ISSNe:
0939-5555, 1432-0584

ANNALS OF HEMATOLOGY  SPRINGER

Tipo:
Article
Páginas:
-
PubMed:
41557074
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
0,994 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 1

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Keywords

  • imatinib; low molecular weight heparin; ponatinib; protein tyrosine kinase inhibitor; antineoplastic agent; BCR ABL protein; imidazole derivative; protein kinase inhibitor; pyridazine derivative; adult; adverse event; anemia; anus fissure; arthralgia; Article; asthenia; blood sampling; bone marrow aspiration; centrifugation; chronic myeloid leukemia; claudication; clinical article; clinical trial; consolidation chemotherapy; constipation; coronavirus disease 2019; degranulation; disease exacerbation; drug efficacy; drug safety; drug withdrawal; dyslipidemia; female; follow up; human; hypertension; imaging; leukocytosis; malaise; male; middle aged; muscle weakness; myalgia; peripheral blood mononuclear cell; phase 2 clinical trial; phenotype; progression free survival; real time polymerase chain reaction; relapse; tachycardia; thrombophlebitis; thrombosis; treatment response; visual disorder; aged; drug therapy; genetics; multicenter study; procedures; treatment outcome; Adult; Aged; An

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