NCT07289087

Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation and CAR-T Therapy

A Real-World Observational Study on Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation (Allo-SCT) and CAR-T Therapy

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 162 (estimated)
• Sponsor: Associazione Qol-one · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

3.1. Overview Prospective, multicenter, observational cohort study comparing short-term PROs measured with the HM-PRO between two exposure groups: patients undergoing allogeneic stem cell transplantation (allo-SCT) and patients receiving CAR-T cell therapy. Patients will be enrolled at hospital admission for the index inpatient procedure and followed through the inpatient stay (admission → discharge). The study is non-randomized and designed to describe trajectories of symptoms and HRQoL and to estimate the between-group difference in deterioration of HM-PRO scores (primary estimand: mean difference in change score, CAR-T vs allo-SCT).

Conditions

• Quality of Life
• Patient Reported Outcome (PRO)
• Allogeneic Blood and Marrow Transplantation (BMT)
• CAR T Cell Therapy

Timeline

• Start date: 2026-02-15
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2025-12-17
• Last updated: 2025-12-17