Safety and efficacy of rituximab in patients with diffuse large B-cell lymphoma in Malawi: A prospective, single-arm, non-randomised phase 1/2 clinical trial
The Lancet Global Health Jun 20, 2021
Kimani S, Painschab MS, Kaimila B, et al. - Among patients suffering from diffuse large B-cell lymphoma (DLBCL), this prospective, single-arm, non-randomised phase 1/2 clinical trial was run to determine whether rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) would be a safe as well as efficacious treatment option for these patients. In this study conducted in Malawi, eligible patients were administered intravenous rituximab 375 mg/m 2 , cyclophosphamide 750 mg/m 2 , doxorubicin 50 mg/m 2 , and vincristine 1·4 mg/m 2 (maximum 2 mg/m 2 ), and oral prednisone 100 mg or an equivalent drug every 21 days for up to six cycles. Overall, 37 eligible patients received R-CHOP. Twelve patients suffered grade 3 or 4 non-haematological toxic impacts, and 26 (70%) patients encountered grade 3 or 4 neutropenia. A complete response was achieved in 22 (59%) cases, and overall survival at 12 months and 24 months was 68% and 55%, and progression-free survival at these time points was 59% and 53%. In this first completed clinical trial on DLBCL focused on sub-Saharan African populations, the feasibility, safety as well as the efficacy of R-CHOP could be seen in DLBCL patients in Malawi. Findings could be valuable for emerging cancer management programmes in sub-Saharan Africa.
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