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

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ClinicalTrials.gov Identifier: NCT04624893
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jianqiu Wu, Jiangsu Cancer Institute & Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Diffuse Large B-Cell Lymphoma (DLBCL) Drug: Polatuzumab Vedotin-Piiq

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 Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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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 Name: Polatuzumab Vedotin


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients enrolled in the Pola CUP program in China
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624893


Contacts
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Contact: Jianqiu Wu, Ph.D +86-13951671579 wujq211@163.com

Locations
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China, Jiangsu
Jiangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Jianqiu Wu, Ph.D    +86-13956171579    wujq211@163.com   
Sponsors and Collaborators
Jiangsu Cancer Institute & Hospital
Investigators
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Principal Investigator: Jifeng Feng, Ph.D Jiangsu Cancer Institute & Hospital
More Information
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Responsible Party: Jianqiu Wu, Director of lymphoma department, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT04624893    
Other Study ID Numbers: PolaCUP
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Jianqiu Wu, Jiangsu Cancer Institute & Hospital:
Diffuse Large B-Cell Lymphoma (DLBCL)
Polatuzumab Vedotin
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs