Feasibility and Effectiveness of CALGB 10403 Protocol in Adolescent and Young Adult Patients with Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma: A Study at Seyed Al-Shohada Hospital, Isfahan, Iran.
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Background: Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) are rare blood cancers with poorer survival in adolescents and young adults (AYAs) than in children. Pediatric-inspired regimens like CALGB 10403 have improved outcomes in AYAs. This study evaluated the effectiveness, feasibility, and treatment-related toxicities of CALGB 10403 in AYAs with ALL/LBL treated at Seyed Al-Shohada Hospital, Isfahan, Iran, from December 2021 to May 2024 Materials and Methods: AYAs aged 17-39 with newly diagnosed ALL/LBL (excluding Burkitt, Ph+, and prior treatment) were included. Baseline characteristics and outcomes of interest (induction response, event-free and overall survivals) were collected. Induction response was assessed via bone marrow (ALL) or CT scan/biopsy (LBL). Minimal residual disease (MRD) was evaluated by flow cytometry. Treatment-related toxicities were monitored and graded per CTCAE criteria. The feasibility of implementing the CALGB 10403 protocol was evaluated by measuring treatment delays. Results: Seventeen AYA patients with newly diagnosed ALL/LBL (median age 21) were enrolled, mostly male (14/17). Fourteen had ALL, and three had LBL. Extramedullary involvement was seen in 29%, including lymphadenopathy, bulky mediastinal masses, and CNS involvement. Sixteen patients (94%) achieved remission, with no deaths during the induction course. One-year EFS and OS were 77% and 100%, respectively. Common toxicities included hyperbilirubinemia, elevated transaminases, and infections. Treatment delays, mainly from non-adherence, occurred in 53%. Eight patients achieved MRD negativity after Course I. Conclusion: This study provides insights into the first Iranian experience with the CALGB 10403 protocol for AYAs with ALL/LBL, a regimen that has demonstrated encouraging survival outcomes in U.S. trials.