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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-15

Study Completion Date

2027-04-01

Brief Summary

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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).

Detailed Description

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Conditions

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Quality of Life Patient Reported Outcome (PRO) Allogeneic Blood and Marrow Transplantation (BMT) CAR T Cell Therapy

Keywords

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Quality of Life CAR-T cell therapy Allogenic BMT Patient Reported Outcome Leukemia Multiple Myeloma Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAR-T

No interventions assigned to this group

ALLO-SCT

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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QOL-ONE PRO-CT

Identifier Type: -

Identifier Source: org_study_id