Polatuzumab Vedotin in Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma

NCT05006534 | Completed

• 1 other identifier: 202005095RINA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study enrolled patients with relapsed or refractory diffuse large B cell lymphoma treated with polatuzumab vedotin-based chemoimmunotherapies. Patients were allowed to use chemotherapy regimens other than Rituximab and Bendamustine and transplantation following polatuzumab vedotin was also allowed.

Conditions

Relapsed Non Hodgkin Lymphoma; Refractory Lymphoma

Keywords

Diffuse large B-cell lymphoma; Polatuzumab vedotin

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From the use of PoV to death related to any cause

  through study completion, an average of 2 year

Secondary Outcomes (2)

• Overall response rate

  through study completion, an average of 2 year

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average of 2 year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Polatuzumab vedotin

You may qualify if:

• The informed consent form must be signed before any study specific tests or procedures are done
• Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included:
• DLBCL not otherwise specified (NOS)
• T-cell/histiocyte-rich large B-cell lymphoma
• Primary cutaneous DLBCL, leg type
• Epstein-Barr virus (EBV)-positive DLBCL, NOS
• DLBCL associated with chronic inflammation
• Primary mediastinal (thymic) large B-cell lymphoma Refractory disease is defined as no complete remission to first line therapy. Relapsed disease is defined as complete remission to first line therapy followed by disease relapse.
• Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen
• Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

You may not qualify if:

• Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment
• Richter's transformation or prior chronic lymphocytic leukemia (CLL)
• Vaccination with a live vaccine within 4 weeks prior to Treatment
• Received polatuzumab vedotin as part of the first line therapy
• Ongoing treatment or study procedures within any other Investigational Medicinal Product (IMP) clinical trial with the exception of follow-up. In case of a preceding clinical trial, last application of the respective IMP(s) must have been done more than five elimination half-lives before start of study medication in this trial.
• History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
• History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure
• Pregnancy or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Wang YW, Tsai XC, Hou HA, Tien FM, Liu JH, Chou WC, Ko BS, Chen YW, Lin CC, Cheng CL, Lo MY, Lin YC, Lu LC, Wu SJ, Kuo SH, Hong RL, Huang TC, Yao M. Polatuzumab vedotin-based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience. Ann Hematol. 2022 Feb;101(2):349-358. doi: 10.1007/s00277-021-04711-9. Epub 2021 Nov 11.

  PMID: 34766217 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheng-Hong Tsai, MD, MSc, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: August 16, 2021
• Study Start: June 1, 2020
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

TW (1)