Study of Combined Chemotherapy and Stem Cell Transplant in Adults with Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating an integrated treatment approach for adults aged 18 to 60 years with Philadelphia chromosome-negative acute lymphoblastic leukemia Ph- ALL. This study aims to improve treatment success and survival by combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation allo-HSCT. It is a single-arm, open-label, multicenter trial enrolling 50 newly diagnosed patients, focusing on outcomes like disease-free survival and remission rates over two years. The treatment begins with an induction phase using the VICPVEN regimen, which includes vindesine, idarubicin, cyclophosphamide, prednisone, and venetoclax administered on specific days. Patients may receive pre-treatment if they show high white blood cell counts or signs of tumor lysis syndrome. After induction, consolidation therapy involves either Hyper-CVAD or CAM chemotherapy protocols. Eligible patients proceed to allo-HSCT with conditioning regimens and graft-versus-host disease prophylaxis. Non-transplant options include maintenance therapy with similar chemotherapy cycles. The entire treatment is planned to be completed within four months after diagnosis. Participants will undergo regular monitoring for two years, including minimal residual disease testing and adverse event tracking. Researchers will measure remission rates, relapse, overall survival, and treatment-related mortality. Follow-up assessments include clinical evaluations and laboratory tests to track disease status and safety. The study aims to reduce relapse risk and improve long-term outcomes through this intensive, combined therapy approach.

Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL