Pixantrone as Bridging Therapy to Allogenic Transplant or CAR-T Cell Therapy in DLBCL Patients

NCT06760936 | Active Not Recruiting

• 1 other identifier: PIXBRIDGE
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective/prospective observational multicentric study aimed at describing the effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Keywords

pixantrone; allogenic transplant; CAR-T therapy

Outcome Measures

Primary Outcomes (1)

• Effectiveness of pixantrone as bridging therapy to allo-HSCT or CAR-T therapy.

  Number of patients able to proceed to transplant/CAR-T

  through study completion, an average of 2 years

Secondary Outcomes (10)

• Treatment duration

  through study completion, an average of 2 years

• patient's response to the treatment with pixantrone

  through study completion, an average of 2 years

• type of adverse events (AE)

  through study completion, an average of 2 years

• Assessment of OS

  through study completion, an average of 2 years

• causes of discontinuation

  through study completion, an average of 2 years

Eligibility Criteria

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

Study Population

primary care clinic relapse/refractory DLBCL patients

You may qualify if:

• Patients with relapsed or refractory DLBCL who received pixantrone as last line of therapy prior to allo-HSCT or CAR-T cell therapy or patient's whose therapeutic program is treatment with pixantrone prior to allo-HSCT or CAR-T cell therapy.
• Age ≥ 18 years at enrolment.
• Written informed consent (if applicable).

You may not qualify if:

• \) none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pier Luigi Zinzani, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 7, 2025
• Study Start: June 6, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)