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Concurrent intensive chemotherapy and imatinib before and after stem cell transplantation in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Final results of the CSTIBES02 trial

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Background: Imatinib, given concurrently or alternating with chemotherapy, has improved the response and survival of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph(+) ALL) but relapses are still frequent. The aim of this study was to evaluate the feasibility and results of giving imatinib concurrently with intensive chemotherapy, stem cell transplantation and post-transplant imatinib maintenance therapy in patients with newly diagnosed Ph(+) ALL. Design and Methods: This was a phase II study of patients with newly diagnosed Ph(+) ALL given standard chemotherapy, together with imatinib (400 mg/day) until stem cell transplantation, followed by imatinib maintenance therapy for all patients regardless of the molecular status of the disease. Results: Of the 30 patients included, 27 (90%) achieved complete remission, one was resistant to treatment and two died during induction therapy. The percentages of major and complete molecular responses were 86% and 21% after induction, and 81% and 65% after consolidation, respectively. Similar results were observed assessing minimal residual disease by Sow cytometry. Of the 27 patients who achieved complete remission, 21 underwent stem cell transplantation (16 allogeneic, 5 autologous). Imatinib (400 mg/day) could be administered after transplantation for a median of 3.9 months in 12 patients, although it was interrupted in 10 patients (in 2 cases because of side effects of the drug). Nine patients relapsed, four before and five after stem cell transplantation and eight patients died of transplant-related causes. With a median follow-up of 4.1 years, the probabilities (95% CI) of disease-free and overall survival were 30% (15% to 45%) and 30% (16% to 45%), respectively. Conclusions: These results confirm that imatinib is an effective first-line treatment for adult Ph(+) ALL when given concurrently with chemotherapy, making stem cell transplantation feasible in a high proportion of patients. However, post-transplantation imatinib administration was limited, mainly because of transplantation-derived complications rather than drug-specific toxicity.

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RIBERA, Josep maria, ORIOL, Albert, GONZÁLEZ, Marcos, VIDRIALES, Belén, BRUNET, Salut, ESTEVE REYNER, Jordi, POTRO, Eloy del, RIVAS, Concepción, MORENO, Maria josé, TORMO, Mar, MARTÍN REINA, Victoria, SARRÁ, Josep, PARODY, Ricardo, PÉREZ DE OTEYZA, Jaime, BUREO, Encarna, BERNAL, Maria teresa, Programa Español de Tratamiento en
Hematología (PETHEMA), Grupo Español de Trasplante Hemopoyético (GETH). Concurrent intensive chemotherapy and imatinib before and after stem cell
transplantation in newly diagnosed Philadelphia chromosome-positive acute
lymphoblastic leukemia. Final results of the CSTIBES02 trial. _Haematologica_. 2010. Vol. 95, núm. 1, pàgs. 87-95. [consulta: 25 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/126814]

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