BridgeMD
Compares treatment options for Diffuse Large B-Cell Lymphoma
Official title Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
ClinicalTrials.gov ID: NCT06803693
What this study is testing
What is Polatuzumab vedotin?
Polatuzumab vedotin is an investigational medicine, given as an infusion into a vein, 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
- The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
- 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 to 75
You may be able to join if
- Signed Informed Consent Form
- Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
- Previously untreated participants with CD20-positive DLBCL
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
You likely can't join if
- Contraindication to any of the individual components of Pola-RCHP or Zanubrutinib/Lenalidomide/ Decitabine
- Prior solid organ transplantation or SCT
- Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma...
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment...
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
See the full eligibility criteria
- Signed Informed Consent Form
- Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
- Previously untreated participants with CD20-positive DLBCL
- IPI score 2-5
- ECOG Performance Status of 0, 1, or 2
- After 1 cycle of Pola-R-CHP, ctDNA decreased by \< 3.0 LFC
- Life expectancy ≥ 6 months
- Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the...
- Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment
- ANC ≥ 1.0 x 10\^9/L
- PLT ≥ 75 x 10\^9/L
- Contraindication to any of the individual components of Pola-RCHP or Zanubrutinib/Lenalidomide/ Decitabine
- Prior solid organ transplantation or SCT
- Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL
- Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to...
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
- Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
- Serum AST and ALT ≥ 2.5 x ULN
- Total bilirubin ≥ 1.5 x ULN
- Serum creatinine clearance \< 30 mL/min (using Cockcroft-Gault formula)
- Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B...
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA
- Participants with a history of progressive multifocal leukoencephalopathy
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of Pola-RCHP-X
- Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's 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 to 75 years. 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.