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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociazione Qol-one

About this trial

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).

Eligibility criteria

Qualifiers

Diagnosed with a hematologic malignancy (e.g., leukemia, lymphoma, multiple myeloma)

Undergoing either allogeneic SCT or CAR-T therapy

Able and willing to provide written informed consent

Sufficient Italian proficiency to complete the HM-PRO

Disqualifiers

Cognitive or physical impairments that preclude the ability to complete questionnaires

Estimated life expectancy < 7 days at the time of admission

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

162 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators