Clinical trial NCT04624893: A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)
Keywords: Diffuse Large B-Cell Lymphoma (DLBCL)
Polatuzumab Vedotin
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients enrolled in the Pola CUP program in China

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.

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.

Eligibility 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.

Primary outcomes:
measure: Investigator-assessed best overall response (BOR)
timeFrame: 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:
measure: Objective response rate (ORR)
timeFrame: At end of the treatment(up to six cycles, each cycle is 21 days)
measure: Duration of response (DOR)
timeFrame: From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months
measure: Complete response (CR)
timeFrame: At end of the treatment(up to six cycles, each cycle is 21 days)
measure: Progression free survival (PFS)
timeFrame: From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Jifeng Feng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: