Clinical Trial

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

Study acronym: QOL-ONE PRO-CT
Not Yet Recruiting
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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).
Trial Details
NCT Number NCT07289087
Lead Sponsor Associazione Qol-one
Conditions Quality of Life, Patient Reported Outcome (PRO), Allogeneic Blood and Marrow Transplantation (BMT), CAR T Cell Therapy
Enrollment 162 participants
Start Date 2026-02-15
Primary Completion 2027-03-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-17