Table of contents
- Trial overview
- Who was studied
- What was tested
- Trial phases and endpoints
- What the study measured
- Status and size of the study
Trial overview
The available trial for MAPLIRPACEPT was an interventional study, which means the researchers gave study medicines and then measured the results.[1] The study focused on adults with relapsed or refractory diffuse large B cell lymphoma, a type of blood cancer that has come back or has not responded well to earlier treatment.[1]
This trial was designed to learn about both safety and possible anti-cancer effect when MAPLIRPACEPT was used with other study medicines.[1] The study was completed.[1]
Who was studied
The target group was adult participants with relapsed or refractory diffuse large B cell lymphoma.[1] In simple terms, this means the trial was not for healthy volunteers; it was for adults living with this specific lymphoma after earlier treatment did not work well or the disease returned.[1]
The brief summary states that the study used a single dose of obinutuzumab before the main study treatment in these adults.[1] The data do not describe other detailed entry rules, so only the population above can be confirmed from the source.[1]
What was tested
The trial studied MAPLIRPACEPT, also listed as PF-07901801, together with glofitamab.[1] The intervention list also names obinutuzumab, which was given as a single dose before the study medicines in the summary.[1]
These names come directly from the trial record, and PF-07901801 is a synonym for MAPLIRPACEPT in this study.[1] The article does not describe how these medicines work, because the trial data focus on the research plan and outcomes rather than a drug monograph.[1]
Trial phases and endpoints
This was a Phase 1 study, with two parts: Phase 1b and Phase 2.[1] Phase 1b is an early part of research that mainly checks safety and helps choose doses for later testing.[1]
In Phase 1b, the main endpoint was dose-limiting toxicities during the 21-day observation period after Cycle 1 Day 1.[1] Dose-limiting toxicities are side effects serious enough to limit how much treatment can be given.[1]
The Phase 1b goal was to assess safety and tolerability of PF-07901801 and glofitamab after a single dose of obinutuzumab, and then select up to two doses of PF-07901801 for Phase 2.[1] This means the early part of the study helped researchers decide which dose levels should be tested further.[1]
In Phase 2, the main endpoint was overall response using the Lugano Response Classification Criteria 2014, as judged by the investigator.[1] Overall response means how much the cancer shrinks or improves after treatment.[1]
What the study measured
The study measured safety, tolerability, and signs of anti-tumor activity.[1] In patient language, this means the researchers checked whether the treatment could be given safely and whether there were signs that the lymphoma responded.[1]
- Safety: whether the treatment caused harmful effects that mattered for the study.[1]
- Tolerability: how manageable the treatment was for participants.[1]
- Dose selection: choosing the dose levels of PF-07901801 to move forward into Phase 2.[1]
- Anti-tumor activity: checking for signs that the lymphoma improved after treatment.[1]
The trial also used the Lugano Response Classification Criteria 2014 to judge response in Phase 2.[1] This is a standard method used in lymphoma research to measure treatment effect.[1]
Status and size of the study
The study status is completed, so it is no longer enrolling participants.[1] The enrollment was 90 participants.[1]
Only one trial was provided in the source data, so the summary here is based on that single completed study.[1] No other MAPLIRPACEPT trials were included in the source material.[1]
