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).

IF 2 4区医学 Q3 ONCOLOGY Oncology Research and Treatment Pub Date : 2024-01-01 Epub Date: 2024-05-16 DOI:10.1159/000539391

Fabian Lang, Heike Pfeifer, Monika Brüggemann, Eva Hermann, Hubert Serve, Nicola Goekbuget

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引用次数: 0

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.

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一项在新发费城染色体阳性急性淋巴细胞白血病成人患者中开展的多中心随机试验，旨在评估泊纳替尼与伊马替尼联合低强度化疗的疗效，比较最佳应答者中有SCT指征的治疗结束与TKI、blinatumomab和化疗的疗效，并评估blinatumomab在次优应答者中的疗效（GMALL-EVOLVE）。

导读：费城染色体阳性急性淋巴细胞白血病（Ph+ALL）的标准治疗方法（SoC）是以伊马替尼为基础的治疗，结合诱导和巩固化疗，在首次缓解后进行异基因干细胞移植（SCT）。德国成人ALL多中心研究小组（GMALL）报告了一项名为GMALL-EVOLVE的试验，该试验旨在评估基于泊纳替尼的治疗、blinatumomab（blina）治疗对次优应答者的影响，以及对优效应答者省略SoC异基因干细胞移植的可能性。方法在该试验中，伊马替尼与泊纳替尼作为一线治疗与化疗相结合进行随机对比，最佳反应者在SCT和化疗免疫疗法之间进行随机对比，次佳反应者在SCT前接受免疫疗法。该试验的EudraCT注册号为2022-000760-21。结论该试验将回答 Ph+ALL 治疗中的几个重大问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Oncology Research and Treatment ONCOLOGY-

CiteScore

3.20

自引率

0.00%

发文量

期刊介绍： With the first issue in 2014, the journal ''Onkologie'' has changed its title to ''Oncology Research and Treatment''. By this change, publisher and editor set the scene for the further development of this interdisciplinary journal. The English title makes it clear that the articles are published in English – a logical step for the journal, which is listed in all relevant international databases. For excellent manuscripts, a ''Fast Track'' was introduced: The review is carried out within 2 weeks; after acceptance the papers are published online within 14 days and immediately released as ''Editor’s Choice'' to provide the authors with maximum visibility of their results. Interesting case reports are published in the section ''Novel Insights from Clinical Practice'' which clearly highlights the scientific advances which the report presents.