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

NCT07289087 | Not Yet Recruiting

• 1 other identifier: QOL-ONE PRO-CT
• Study Type: observational
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  3 MONTHS

Secondary Outcomes (5)

• To describe PRO trajectories during hospitalization

  3 MONTHS

• To assess differences in PROs based on disease type (e.g., Leukemia, lymphoma, myeloma)

  3 MONTHS

• To assess differences in PROs based on disease status (remission vs progression)

  3 MONTHS

• To assess differences in PROs based on treatment line (first-line vs multiple lines)

  3 MONTHS

• To validate the use of the HM-PRO in the context of inpatient care for advanced therapies.

  3 MONTHS

Study Arms (2)

CAR-T

ALLO-SCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults (≥18 years) with a hematologic malignancy admitted for either (a) allo-SCT or (b) CAR-T cell therapy.

You may qualify if:

• 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

You may not qualify if:

• Cognitive or physical impairments that preclude the ability to complete questionnaires
• Estimated life expectancy \< 7 days at the time of admission

Sponsors & Collaborators

• Associazione Qol-one: lead

MeSH Terms

Conditions

Leukemia; Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 17, 2025
• Study Start: February 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12