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Tests treatment safety and results for Diffuse Large B-Cell Lymphoma
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
ClinicalTrials.gov ID: NCT07001540
What this study is testing
What is Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx)?
Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (Pola-R- GemOx) is an investigational medicine, being studied as a potential treatment for diffuse large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Participants must meet all of the following criteria to participate in the study:
- Age ≥18 years old;
- ineligible for autologous transplantation;
- Sign the Informed Consent Form (ICF);
- CD79b-positive DLBCL confirmed by pathology (including transformed DLBCL, PMBL, HGBCL);
You likely can't join if
- \- people who meet any of the following criteria are not eligible to participate in this study:
- people with any factor that may affect their ability to comply with the protocol, as determined by the investigator, including uncontrollable...
- Known human immunodeficiency virus (HIV) infection or immunoassay positive；
- Viral infections that cannot be controlled by antiviral drugs, such as active herpes virus infection, acute or chronic active hepatitis B, acute or...
- Patients with uncontrolled lymphomas with CNS infiltration (CNS disease diagnosed at initial diagnosis is allowed, provided complete remission of CNS...
- Patients who have previously received oxaliplatin or gemcitabine treatment;
See the full eligibility criteria
- \- Participants must meet all of the following criteria to participate in the study:
- Age ≥18 years old;
- ineligible for autologous transplantation;
- Sign the Informed Consent Form (ICF);
- CD79b-positive DLBCL confirmed by pathology (including transformed DLBCL, PMBL, HGBCL);
- Patients must have received adequate first-line treatment and only first-line treatment, with
- Anti-CD20 monoclonal antibodies (unless the investigator determines that the tumor is CD20-negative)
- Chemotherapy regimens containing anthracyclines
- Recurrent or refractory diseases after first-line immunochemotherapy:
- Refractory disease is defined as not having a complete response to first-line therapy (except for patients who are intolerant to first-line therapy)
- Recurrent disease is defined as disease recurrence after complete response to first-line treatment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, with an expected survival of more than 12 weeks.
- Have at least one measurable two-dimensional lesion identified by clinical examination, CT scan or MRI: ① lymph node \>1.5cm; ② Other non-lymph node lesions ≥1.0cm;
- The main tissues and organs function well: Hematological function: absolute granulocyte count ≥ 1,000/mm3, platelet count ≥ 75,000/mm3; Liver function: ALT/AST \ 30 mL/min, creatinine ≤1.5× upper limit of normal (ULN)...
- \- people who meet any of the following criteria are not eligible to participate in this study:
- people with any factor that may affect their ability to comply with the protocol, as determined by the investigator, including uncontrollable medical, psychological, family, social, or geographical conditions, or those...
- Known human immunodeficiency virus (HIV) infection or immunoassay positive；
- Viral infections that cannot be controlled by antiviral drugs, such as active herpes virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. (Note: chronic HBV carriers or...
- Patients with uncontrolled lymphomas with CNS infiltration (CNS disease diagnosed at initial diagnosis is allowed, provided complete remission of CNS disease is achieved and maintained and no CNS disease is present at...
- Patients who have previously received oxaliplatin or gemcitabine treatment;
- Pregnant or lactating patients;
- Other concurrent serious illness or medical condition that would prevent participation in the study;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.