Study Comparing Ponatinib and Imatinib with Low-Dose Chemotherapy for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Also Evaluating the Use of Blinatumomab and Stem Cell Transplant Options Based on Treatment Response

What this Trial Is About

Researchers are evaluating treatments for adults aged 18 to 65 with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph ALL. This phase 2 multicenter trial, sponsored by Goethe University, aims to compare the current standard treatment of Imatinib plus low-dose chemotherapy with Ponatinib plus chemotherapy. It also seeks to explore different treatment strategies based on patients molecular response to therapy, including the use of Blinatumomab and the role of stem cell transplantation. Participants receive either Imatinib 600 mg once daily or Ponatinib 45 mg once daily reduced to 30 mg after induction, both combined with low-dose chemotherapy during induction and consolidation phases. Patients with a good molecular response are randomized to either end therapy with indication for stem cell transplantation or continue treatment with TKI, chemotherapy, and Blinatumomab. Those with poor molecular response receive Blinatumomab followed by end of therapy and transplantation indication. Stem cell transplantation itself is not part of the trial. During the study, participants undergo molecular evaluations for BCR-ABL1, regular monitoring of blood counts, and assessments of treatment response. Researchers measure overall survival in molecular complete remission patients receiving TKI-chemotherapy-Blinatumomab versus standard end of therapy with transplantation indication. Safety and remission rates are also tracked. The study involves follow-up for up to four years from randomization to assess long-term outcomes and treatment effects.

Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT