Patient-Reported Outcomes in Allogeneic Stem Cell Transplantation and CAR-T Therapy
NCT07289087 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 162
Last updated 2025-12-17
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
Sponsors & Collaborators
-
Associazione Qol-one
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-15
- Primary Completion
- 2027-03-01
- Completion
- 2027-04-01
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