Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Blood and Marrow Transplantation (BMT) | — | UNRESOLVED | — |
| CAR T Cell Therapy | — | UNRESOLVED | — |
| Patient Reported Outcome (PRO) | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- CAR-T
- label
- ALLO-SCT
Primary outcomes (1)
- measure
- To assess and compare short-term patient-reported outcomes [PROs (symptom burden and QoL impact)] between patients receiving allo-SCT and CAR-T therapy using the HM-PRO questionnaire (Impact Scale, Symptoms Scale) from admission to hospital discharge
- timeFrame
- 3 MONTHS
- description
- The primary outcome aims to evaluate the impact of CAR-T therapy and allogeneic transplantation on patients' quality of life using a specific questionnaire (HM-PRO), which assesses PROs (quality of life and symptoms) in hematologic patients, with the goal of determining whether there are differences between the two patient groups. In the HM-PRO questionnaire values range from 0 to 100. Lower values correspond to a better quality of life and a lower symptom burden.
Secondary outcomes (5)
- measure
- To describe PRO trajectories during hospitalization
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Signed informed consent Exclusion Criteria: * Cognitive or physical impairments that preclude the ability to complete questionnaires * Estimated life expectancy \< 7 days at the time of admission
References
Publications (0)
Data not yet available