My name is Juan Alderucho. I am a hematologist and lymphoma specialist at University of Miami, Sylvester Complegesi Cancer Center in Miami, Florida. And during ASH, I will present our investigative study on a fixed duration of long-cast tuxima tesserine with retuximab in patients with relapsed or refractory follicular lymphoma. In this clinical trial, we enrolled 33 patients with relapsed or refractory follicular lymphoma presenting progression of disease within 24 months from initial therapy or those with meeting health criteria. That means a high disease burden at the time of relapse. In this clinical trial, we enrolled 33 patients with these characteristics. The majority of them were older than 65 years old and presented stage 3 or stage 4 follicular lymphoma at the time of relapse. Also, most of these patients presented a high tumor burden and 54% presented progression of disease within 24 months or POD 24. In this clinical trial, we gave long-cast tuximab associated with retuximab. The first response assessment was done at week 12. Subsequently, the patient received three more doses of long-cast tuximab or one more dose of retuximab and the new response assessment was performed at week 21. Those patients that achieved a complete response, meaning no evidence of disease on PET CT at week 21, they discontinued long-cast tuximab and received two more doses of retuximab. Those patients achieved partial responses to continue both drugs for a total of 18 more weeks. At the end of treatment, we performed the PET CT and all patients discontinued therapy at that time point. A total of 27 patients underwent the response assessment and the current data cutoff of November 26. The overall response rate was 95%, 96% and the complete response rate was 85%. The median progression fee survival has not been reached. The six months progression fee survival was 96% and the median overall survival of 95%. The toxicity, the most common were grade 1 toxicities. The most common was a decrease in the neutrophils and also some anemia and low platelets, thrombocytopenia. However, no patients required blood transfusions during the study course. The non-hematological toxicity, the most common was increasing the liver function test in the liver enzymes, specifically the alkaline for fatase. Also approximately 25% of the patients developed a rash, skin rash and a photosensitivity that is a common characteristic of long-cast toxin map. And a significantly lower percent of the patients, approximately 12.5% of the patients developed fluid accumulation that is also known toxicity of long-cast toxin map. However, the majority were grade 1 and manageable with diuretics such as spinolactone and Lasix that address that problem. Based on this data, the next steps is to develop a multi-center study trying to expand the current cohort beyond the 39 patients that were originally planned for this study to 100 patients to confirm the safety and efficacy that was observed in this single institution clinical trial.
HealthTree • December 11, 2023