A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin

November 10, 2020 updated by: Jianqiu Wu, Jiangsu Cancer Institute & Hospital

A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin in the Treatment of Patients With Transplantation Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma

To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center retrospective observational study. It aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), who met the criteria to access Pola through the compassionate use program (CUP). Based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (CRF) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.

Study Type

Observational

Enrollment (Anticipated)

35

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients enrolled in the Pola CUP program in China

Description

Inclusion Criteria:

Hospitalized patients Patients who enrolled in the Pola CUP program and met the following criteria:

  • Histologically confirmed DLBCL, patients have exhausted all therapeutic options for DLBCL and have been treated with at least two prior lines of therapy including R-CHOP (or similar regimen for 1L DLBCL)
  • Not considered to be eligible for Bone Marrow Transplantation (BMT) (both allogenic or autologous)
  • Have documented recent progression following or during last treatment, or became intolerant to the last treatment
  • Does not have ≥ Grade 2 peripheral neuropathy(PN) prior to receiving Pola
  • Patients treated with Pola-BR or Pola-R regimens

Exclusion Criteria:

  • Patients participating in other clinical studies of Pola.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pola BR/R
Patients with R/R DLBCL who are enrolled in the Pola CUP program in China, and treated with Pola-BR or Pola-R regimens.
Drug: Polatuzumab Vedotin-Piiq
Patients will receive a total of six cycles of Pola in combination with rituximab and bendamustine or in combination with only rituximab. A cycle is typically 21 days for DLBCL.
Other Names:
  • Polatuzumab Vedotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-assessed best overall response (BOR)
Time Frame: From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days)
Best overall response (BOR) assessed by the investigator, is based on either PET-CT or CT, and defined as the percentage of patients with CR or PR.
From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: At end of the treatment(up to six cycles, each cycle is 21 days)
Objective response rate (ORR) assessed by the investigator at the end of treatment (EOT), is defined as the percentage of patients with CR or PR at the end of treatment.
At end of the treatment(up to six cycles, each cycle is 21 days)
Duration of response (DOR)
Time Frame: From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months
DOR is defined as the time from initial complete response (CR) or partial response (PR) to disease progression, relapse, or death from any cause, whichever occurred first.
From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months
Complete response (CR)
Time Frame: At end of the treatment(up to six cycles, each cycle is 21 days)
CR rate is defined as the percentage of patients with CR.
At end of the treatment(up to six cycles, each cycle is 21 days)
Progression free survival (PFS)
Time Frame: From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months
PFS is defined as the time from the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first.
From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months

Collaborators and Investigators

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

Sponsor

Jiangsu Cancer Institute & Hospital

Investigators

  • Principal Investigator: Jifeng Feng, Ph.D, Jiangsu Cancer Institute & Hospital

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)

December 12, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 5, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PolaCUP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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