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

NCT04624893 | Unknown FDA Drug

• 1 other identifier: PolaCUP
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Keywords

Diffuse Large B-Cell Lymphoma (DLBCL); Polatuzumab Vedotin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective response rate (ORR)

  At end of the treatment(up to six cycles, each cycle is 21 days)

• Duration of response (DOR)

  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)

  At end of the treatment(up to six cycles, each cycle is 21 days)

• Progression free survival (PFS)

  From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months

Study Arms (1)

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

Interventions

Polatuzumab Vedotin-Piiq DRUG

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.

Also known as: Polatuzumab Vedotin

Pola BR/R

Eligibility Criteria

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

Study Population

All patients enrolled in the Pola CUP program in China

You may qualify if:

• 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

You may not qualify if:

• Patients participating in other clinical studies of Pola.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

polatuzumab vedotin

Condition Hierarchy (Ancestors)

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

Study Officials

• Jifeng Feng, Ph.D

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiu Wu, Ph.D

CONTACT

+86-13951671579; wujq211@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma department

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 12, 2020
• Study Start: December 12, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

CN (1)