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

Jiangsu Cancer Hospital

Status: Unknown

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Treatments: Drug: Polatuzumab Vedotin-Piiq

Study type: Observational

Funder types: Other

Identifiers

NCT04624893

PolaCUP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

35 participants in 1 patient group

Pola BR/R

Description:

Patients with R/R DLBCL who are enrolled in the Pola CUP program in China, and treated with Pola-BR or Pola-R regimens.

Treatment:

Drug: Polatuzumab Vedotin-Piiq