BridgeMD
New treatment option for Relapsed/Refractory Large B-Cell Lymphoma
Official title Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL
ClinicalTrials.gov ID: NCT06489808
What this study is testing
What is Linperlisib?
Linperlisib is an investigational medicine, being studied as a potential treatment for relapsed/refractory 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
- To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.
- 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
- Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), follicular lymphoma grade 3B...
- Relapsed or refractory after first-line immunochemotherapy (which must include CD20 monoclonal antibody and anthracycline) 1)Refractory is defined as...
- people must have at least 1 measurable lesion/evaluable lesion that meets the 2014 version of the Lugano Lymphoma Evaluation Criteria.
- people has no known or suspected central nervous system involvement by lymphoma.
- Previous treatment with any antineoplastic therapy (including radiation therapy, chemotherapy, hormonal therapy, surgery, or molecular targeted...
You likely can't join if
- Other malignancies within the last 5 years, except radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma...
- Previous autologous or allogeneic hematopoietic stem cell transplantation.
- History of Richter transformation.
- Received \> 1 line of systemic antineoplastic therapy.
- Prior treatment with PI3K inhibitors.
- Known hypersensitivity to trial products.
See the full eligibility criteria
- Histologically confirmed large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma unspecified (DLBCL, NOS), follicular lymphoma grade 3B (FL, 3B), high-grade B-cell lymphoma unspecified (HGBCL, NOS)...
- Relapsed or refractory after first-line immunochemotherapy (which must include CD20 monoclonal antibody and anthracycline) 1)Refractory is defined as failure to achieve a complete response to first-line therapy...
- people must have at least 1 measurable lesion/evaluable lesion that meets the 2014 version of the Lugano Lymphoma Evaluation Criteria.
- people has no known or suspected central nervous system involvement by lymphoma.
- Previous treatment with any antineoplastic therapy (including radiation therapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy) for which participation in this trial must have exceeded 2 weeks...
- Age ≥ 18 years.
- ECOG score 0-2.
- Expected survival ≥ 3 months.
- Women of Childbearing Potential people must have a negative serum/urine pregnancy test within 7 days prior to the first dose; female people of childbearing potential and male people with partners of childbearing...
- Able to comply with the trial protocol as judged by the investigator.
- Each subject (or legally acceptable representative) voluntarily joined the study and signed an informed consent form. \-
- Other malignancies within the last 5 years, except radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast, and carcinoma in situ of the cervix.
- Previous autologous or allogeneic hematopoietic stem cell transplantation.
- History of Richter transformation.
- Received \> 1 line of systemic antineoplastic therapy.
- Prior treatment with PI3K inhibitors.
- Known hypersensitivity to trial products.
- Active viral, bacterial, or fungal infection requiring treatment (eg, pneumonia, etc.).
- Requiring prolonged systemic hormones (at doses equivalent to \> 10 mg prednisone/day) or any other form of immunosuppressive therapy. people taking inhaled or topical corticosteroids may be enrolled.
- Concomitant diseases and medical history:
- Multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, ileus, etc.).
- Patients with a history of psychotropic substance abuse who cannot quit or have mental disorders.
- people with any severe and/or uncontrolled disease including: 1)Unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg). 2)Patients with ≥ grade 2 myocardial...
- Patients with active or history of autoimmune diseases that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis...
- Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
- Positive pregnancy test at baseline in female patients who are pregnant, lactating, or of childbearing potential.
- Concurrent medical conditions that, in the investigator 's judgment, would seriously compromise the patient' s safety or the patient 's completion of the study. \-
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Tianjin, Tianjin 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.