학술논문

A Multicentre, Randomized Trial in Adults with de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia to Assess the Efficacy of Ponatinib versus Imatinib in Combination with Low-Intensity Chemotherapy, to Compare End of Therapy with Indication for Stem Cell Transplantation versus Tyrosine Kinase Inhibitor, Blinatumomab, and Chemotherapy in Optimal Responders, and to Evaluate Blinatumomab in Suboptimal Responders (GMALL-EVOLVE).
Document Type
Academic Journal
Author
Lang F; Department of Medicine, Hematology/Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.; Pfeifer H; Department of Medicine, Hematology/Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.; Brüggemann M; Department of Hematology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.; Hermann E; Institute of Biostatistics and Mathematical Modelling, Goethe University Frankfurt, Frankfurt, Germany.; Serve H; Department of Medicine, Hematology/Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.; Goekbuget N; Department of Medicine, Hematology/Oncology, University Hospital, Goethe University Frankfurt, Frankfurt, Germany.
Source
Publisher: S. Karger Country of Publication: Switzerland NLM ID: 101627692 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2296-5262 (Electronic) Linking ISSN: 22965270 NLM ISO Abbreviation: Oncol Res Treat Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ALL) is treated as standard of care (SoC) by imatinib-based treatment combined with induction and consolidation chemotherapy followed by allogeneic stem cell transplantation (SCT) in first remission. The German Multicenter ALL Study Group for Adult ALL (GMALL) reports about a trial to evaluate the impact of ponatinib-based therapy, blinatumomab treatment for suboptimal responders, and the possibility of omission of SoC Allo SCT in optimal responders entitled GMALL-EVOLVE.
Methods: Herein, imatinib is randomized versus ponatinib as frontline treatment combined with chemotherapy, optimal responders also get randomized between SCT and chemo-immunotherapy, and suboptimal responders receive immunotherapy before SCT. The trial is registered under the EudraCT number 2022-000760-21.
Conclusion: This trial will answer several major questions in the treatment of Ph+ALL.
(© 2024 The Author(s). Published by S. Karger AG, Basel.)