Clinical trial · Observational
A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin
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
NCT04624893CI-TRIAL-00048238unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polatuzumab Vedotin-Piiq | Drug | Polatuzumab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Polatuzumab Vedotin-Piiq
Primary outcomes (1)
- 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)
- description
- 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 outcomes (4)
- measure
- Objective response rate (ORR)
- timeFrame
- At end of the treatment(up to six cycles, each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.