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

August 8, 2021 updated by: National Taiwan University Hospital

The Efficacy and Adverse Effect of Polatuzumab Vedotin in Patients With Diffuse Large B Cell Lymphoma: an Observation Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Polatuzumab vedotin has been demonstrated to be an effective treatment for patients with relapsed/refractory diffuse large B cell lymphoma in an international phase II clinical trial. The clinical trials was conducted in Europe and the United States. Although there is a phase III trial about polatuzumab vedotin in newly diagnosed patients with diffuse large B cell lymphoma, the double-blind design has limited the efficacy assessment and side effect observation, making it difficult to provide clinicians with further information.

This program hopes to evaluate the clinical course and treatment response of these patients in order to facilitate clinicians' understanding of this drug and to improve patients' quality of life and medical care, as well as to prevent the occurrence of related complications and treatment toxicity.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with Polatuzumab vedotin

Description

Inclusion Criteria:

  1. The informed consent form must be signed before any study specific tests or procedures are done
  2. Adult male and female patients ≥20 years at the time of inclusion in the study Ability to understand and follow study-related instructions

  3. 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.
  4. 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
  5. Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration
  6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
  7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

  1. Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment
  2. Richter's transformation or prior chronic lymphocytic leukemia (CLL)
  3. Vaccination with a live vaccine within 4 weeks prior to Treatment
  4. Received polatuzumab vedotin as part of the first line therapy
  5. 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.
  6. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
  7. History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure
  8. Pregnancy or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: through study completion, an average of 2 year
From the use of PoV to death related to any cause
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: through study completion, an average of 2 year
The assessment is based on PET/CT or contrast CT, as determined by the investigator. Including complete remission and partial remission
through study completion, an average of 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: through study completion, an average of 2 year
Will estimate the safety and tolerability of polatuzumab vedotin when added to intensive chemotherapy regimens
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Cheng-Hong Tsai, MD, MSc, PhD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ACTUAL)

June 29, 2021

Study Completion (ACTUAL)

June 29, 2021

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

August 8, 2021

First Posted (ACTUAL)

August 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 8, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202005095RINA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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