Table of contents
- Clinical trial overview
- Who was studied
- What the trial measured
- Trial design and phase
- What the trial record shows
Clinical trial overview
The available trial of Adct-402 was a Phase 2 study called LOTIS-9.[1] It studied a treatment plan using Loncastuximab Tesirine with rituximab in people with previously untreated lymphoma.[1]
The study was open-label, which means the patients and the study team knew what treatment was being given.[1] It was completed and enrolled 93 people.[1]
Who was studied
The trial focused on people with previously untreated diffuse large B-cell lymphoma (DLBCL).[1] It also included patients with high-grade B-cell lymphoma and grade 3b follicular lymphoma.[1]
Two study groups were described in the record.[1] Cohort A included unfit patients, while Cohort B included frail patients or patients with cardiac comorbidities, meaning other heart-related health problems.[1]
Cohort B also included people who were not eligible for standard R-mini-CHOP, a lower-intensity treatment plan used for some patients who cannot receive stronger therapy.[1]
What the trial measured
The main outcome was complete response rate, which means the share of patients whose cancer could not be found by the study’s response rules.[1] This was measured in both Cohort A and Cohort B.[1]
For Cohort B, the trial also measured tolerability, which is how well patients can stay on treatment.[1] In this study, tolerability was defined by the percentage of patients who finished 4 treatment cycles out of all patients in that group.[1]
Trial design and phase
This was a Phase 2 interventional study.[1] Interventional means the researchers gave a treatment and then measured the results, rather than only observing what happened naturally.[1]
The brief summary says the study looked at a response-adapted treatment of Lonca-R in unfit patients and in frail patients or patients with heart comorbidities.[1] A response-adapted plan means treatment decisions were based on how the disease responded during the study.[1]
What the trial record shows
The trial record shows that NCT05144009 is completed and includes 93 participants.[1] The study was designed to learn whether this approach could produce complete responses and whether frail or heart-affected patients could tolerate the treatment plan.[1]
Based on the record, the main focus was not on healthy volunteers or on advanced disease after many prior treatments.[1] Instead, it focused on people who had not yet been treated and who might need a less intensive approach because of weakness, frailty, or other health problems.[1]
