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Phase I Study of Subcutaneous Rituximab Hyaluronidase Combined With CHOP Chemotherapy for the Treatment of Diffuse Large B-Cell Lymphoma in Uganda

Purpose

Patients with diffuse large B-cell lymphoma (DLBCL) in low-resource areas often have worse outcomes than those in wealthier regions. Rituximab, a medication that helps fight this cancer, can improve survival rates when combined with chemotherapy. However, its use is limited in low-resource countries due to a lack of infusion centers. Subcutaneous rituximab (sqR) could be a solution, but its safety and effectiveness in these settings have not been tested.

Methods

This study involved patients aged 18 and older with newly diagnosed DLBCL. The first group of 6 patients received intravenous rituximab along with chemotherapy (CHOP) and then switched to sqR for later treatments. The second group of 12 patients received sqR with CHOP for all treatments. We looked at safety and how well patients responded to the treatment.

Results

From October 2019 to October 2022, 18 patients participated, with an average age of 36.5 years. Half of the patients experienced a common side effect called neutropenia. Out of 18 patients, 15 completed their treatment. A remarkable 93.3% achieved complete remission, while one patient had a partial response. The overall survival (OS) rates at 12 months were 83%, and at 24 months, they were 66%. These results are significantly better than historical data from similar patients.

Conclusion

This study shows that sqR combined with CHOP is safe and effective for Ugandan patients with DLBCL. The survival rates are comparable to those seen in wealthier countries. This research not only demonstrates the effectiveness of this treatment but also enhances healthcare capabilities in Uganda and similar low-resource settings.

Opportunities Based on Trial Data

1. Define Measurable Outcomes: Set clear goals for clinics and patients based on the study’s findings.

2. Select AI Tools: Choose AI solutions that meet specific clinical needs to improve patient care.

3. Implement Step by Step: Start with a pilot project to track results using AI solutions and assess their real-world impact.

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