Phase II Study of Bortezomib-Based Treatment for Adults Aged 16 to 60 With Refractory or Relapsed Acute Lymphoblastic Leukemia

What this Trial Is About

This research aims to evaluate the complete response rate of a bortezomib-based salvage treatment in adults aged 16 to 60 with refractory or relapsed acute lymphoblastic leukemia ALL. ALL is a rare blood cancer in adults with about half surviving long-term under current treatments, but those with resistant or returning disease have fewer options and worse outcomes. This study seeks to compare the results of this treatment with existing data and historical outcomes for relapsed or refractory ALL cases. Participants will receive one or two courses of a combination regimen including bortezomib, vincristine, doxorubicin, peg-asparaginase, dexamethasone, and intrathecal chemotherapy methotrexate and dexamethasone. This treatment aims to help patients achieve remission and proceed to allogeneic hematopoietic stem-cell transplantation HSCT. The study will also assess safety, feasibility, and rates of side effects such as febrile neutropenia, liver toxicity, neurotoxicity, and treatment-related mortality. During the study, researchers will monitor participants closely, measuring complete response within 30 days and tracking event-free survival, overall survival, and measurable residual disease MRD negativity over one year. They will also observe the number able to undergo HSCT after treatment. Participants will have regular evaluations including blood tests and clinical assessments to ensure safety and effectiveness are carefully followed throughout the trial period ending in 2029.

Bortezomib-based Regimen for Refractory or Relapsed Acute Lymphoblastic Leukemia