| Title: |
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 |
| Authors: |
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.; Pfeifer, Heike |
| Publisher Information: |
Taylor and Francis Group |
| Publication Year: |
2025 |
| Collection: |
Cardiff University: ORCA (Online Research @ Cardiff) |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://orca.cardiff.ac.uk/id/eprint/176303/1/Final%20analysis%20of%20the%20GMALL-PH-01%20trial%20phase%20II%20study%20of%20standard%20chemotherapy%20in%20combination%20with%20dasatinib%20in%20first%20line%20treatment%20of%20Philadelphia.pdf; 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. https://orca.cardiff.ac.uk/view/cardiffauthors/A2177092Z.html orcid:0000-0001-9559-1330 orcid: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 66 (6) , pp. 1079-1087. 10.1080/10428194.2025.2460737 https://doi.org/10.1080/10428194.2025.2460737 file https://orca.cardiff.ac.uk/id/eprint/176303/1/Final%20analysis%20of%20the%20GMALL-PH-01%20trial%20phase%20II%20study%20of%20standard%20chemotherapy%20in%20combination%20with%20dasatinib%20in%20first%20line%20treatment%20of%20Philadelphia.pdf |
| DOI: |
10.1080/10428194.2025.2460737 |
| Availability: |
https://orca.cardiff.ac.uk/id/eprint/176303/; https://doi.org/10.1080/10428194.2025.2460737 |
| Rights: |
cc_by_nc_nd_4_0 |
| Accession Number: |
edsbas.B868A205 |
| Database: |
BASE |