Final analysis of the GMALL-PH-01 trial: phase II study of standard chemotherapy in combination with dasatinib in first line treatment of Philadelphia chromosome positive acute lymphoblastic leukemia

Lang, Fabian, Voss, Andreas, Kobbe, Guido, Junghanss, Christian, Beck, Joachim, Viardot, Andreas, Wendelin, Knut, Panse, Jens, Heberling, Lisa, Vucinic, Vladan, Böll, Boris, Topp, Max, Hoelzer, Dieter, Serve, Hubert, Goekbuget, Nicola, Ottmann, Oliver G. ORCID: https://orcid.org/0000-0001-9559-1330 and Pfeifer, Heike 2025. Final analysis of the GMALL-PH-01 trial: phase II study of standard chemotherapy in combination with dasatinib in first line treatment of Philadelphia chromosome positive acute lymphoblastic leukemia. Leukemia & Lymphoma 10.1080/10428194.2025.2460737

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Abstract

Imatinib (IMA) plus chemotherapy followed by allogeneic hematopoietic cell transplantation (HCT) is established treatment for Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). We investigated the use of dasatinib (DASA) combined with intensive chemotherapy in ALL (18–55 years) first-line in a prospective, multicenter phase II trial by the GMALL study group. 140 mg DASA QD was used with a pediatric-based induction and consolidation chemotherapy according to GMALL 07/2003 protocol with recommended consecutive HCT. Nineteen of 20 planned patients were enrolled in 12 centers. The hematologic CR rate after induction was 79% with an overall MRD negativity rate of 62.5%. Six patients died during induction and two discontinued therapy. This regimen achieved deep molecular responses but was associated with a higher than expected early mortality (21%) and was stopped prematurely due to toxicities. The GMALL therefore adopted a combination of low intensity chemotherapy plus IMA as its current induction regimen.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Schools > Medicine
Additional Information:	License information from Publisher: LICENSE 1: URL: http://creativecommons.org/licenses/by-nc-nd/4.0/, Start Date: 2025-02-08
Publisher:	Taylor and Francis Group
ISSN:	1042-8194
Date of First Compliant Deposit:	19 February 2025
Date of Acceptance:	26 January 2025
Last Modified:	19 Feb 2025 11:00
URI:	https://orca.cardiff.ac.uk/id/eprint/176303

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