NCT07289087Not yet recruiting
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 · Last updated 17 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 162 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 15 Feb 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Associazione Qol-one
- Diseases
- Multiple myeloma
- NCT number
- NCT07289087
What you commit to
- Study type: Observational
- Planned participants: 162
- From 15 Feb 2026 to the primary completion date, 1 Mar 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Cognitive or physical impairments that preclude the ability to complete questionnaires
- Estimated life expectancy \< 7 days at the time of admission
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.