Actively Recruiting
Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation
Led by Fudan University · Updated on 2025-06-19
130
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
F
Fujian Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multicenter, single-arm clinical study designed to evaluate the efficacy and safety of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as salvage therapy for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) patients ineligible for autologous transplantation.
CONDITIONS
Official Title
Evaluation of the Efficacy and Safety of Polatuzumab Vedotin Combined With Rituximab, Gemcitabine, and Oxaliplatin (Pola-R-GemOx) as Salvage Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients Ineligible for Autologous Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older
- Ineligible for autologous transplantation
- Signed informed consent form
- Confirmed CD79b-positive Diffuse Large B-Cell Lymphoma (DLBCL), including transformed DLBCL, PMBL, or HGBCL
- Received adequate first-line treatment only with anti-CD20 monoclonal antibodies (unless tumor is CD20-negative) and anthracycline-containing chemotherapy
- Have relapsed or refractory disease after first-line immunochemotherapy
- Refractory disease defined as not achieving complete response to first-line therapy (except intolerance cases)
- Recurrent disease defined as disease recurrence after complete response to first-line treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 with expected survival over 12 weeks
- At least one measurable lesion: lymph node >1.5 cm or other lesion ≥1.0 cm by clinical exam, CT, or MRI
- Adequate organ function including hematological, liver, renal, lung, and cardiac function
- Fertile patients willing to use effective contraception during treatment and for 120 days after last dose
You will not qualify if you...
- Any condition affecting ability to comply with protocol as judged by investigator
- Known HIV infection or positive immunoassay
- Uncontrolled viral infections not manageable by antiviral drugs (active herpes, acute/chronic hepatitis B or C)
- Uncontrolled lymphomas with central nervous system infiltration (unless CNS disease is in complete remission and absent at recurrence)
- Previous treatment with oxaliplatin or gemcitabine
- Pregnant or breastfeeding
- Other serious illnesses or medical conditions preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200231
Actively Recruiting
Research Team
W
Wenhao Zhang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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