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

Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624893
• Other study ID #: PolaCUP
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Jianqiu Wu, Ph.D
• Phone: +86-13951671579
• Email: wujq211[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma (DLBCL)
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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.

Locations

Country	Name	City	State
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-assessed best overall response (BOR)	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	Objective response rate (ORR)	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)
Secondary	Duration of response (DOR)	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
Secondary	Complete response (CR)	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)
Secondary	Progression free survival (PFS)	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