Chapter 7: Clinical Study

Following the eye-opening PET scan in January 2023 that revealed a substantial uptick in uptake in my left pelvic area, it was clear that a more decisive course of action was needed. A bone marrow biopsy and a biopsy of the left pelvic area were slated. The results from the bone marrow biopsy unveiled a concerning 5%-10% impact of Mantel Cell Lymphoma (MCL) on the bone marrow. Simultaneously, the biopsy of the left pelvic area affirmed our ongoing battle with MCL, thankfully without any metamorphosis into a different lymphoma subtype.

It was at this juncture that Dr. Rajguru suggested enrolling in a clinical study, EA4181, a regimen he believed would be not only effective but also manageable for me. Fortunately, I met all the criteria for acceptance into this clinical study. The study, divided into two arms (A and B), aimed to evaluate the effectiveness of adding the study drug acalabrutinib, an unusual choice for initial MCL treatment. Randomly assigned to arm B, I found myself receiving the top-of-the-line chemotherapy in addition to the study drug, another form of chemotherapy.

The clinical study unfolds over six cycles, each lasting 28 days. In the initial three cycles, I would take the oral study drug acalabrutinib twice a day throughout the entire cycle. On day 1 of each cycle, I would undergo induction therapy, receiving rituximab and bendamustine via IV. Day 2 of the first three cycles would involve more bendamustine administered via IV. Conveniently, all these IV sessions could be done on an outpatient basis at the Carbone clinic at One South Park.

Transitioning to cycles 4-6, the acalabrutinib dosage would be confined to days 1-7 and 22-28. Days 1 and 2 of these cycles, however, would find me hospitalized at UW Madison Hospital. On day 1, I would receive rituximab and, concurrently, be subjected to high-dose cytarabine for three hours every 12 hours, totaling four doses over 48 hours. Due to the specific administration schedule of cytarabine, outpatient treatment wasn’t feasible.

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