Actively Recruiting
Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-07-08
89
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of Linperlisib combined with standard immunochemotherapy in patients with R/R LBCL.
CONDITIONS
Official Title
Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed large B-cell lymphoma including DLBCL, NOS, FL grade 3B, HGBCL, NOS, DLBCL/HGBCL with MYC and BCL2 rearrangements, or FL transformed DLBCL without previous indolent lymphoma
- Relapsed or refractory after first-line immunochemotherapy including CD20 monoclonal antibody and anthracycline
- At least one measurable or evaluable lesion meeting 2014 Lugano Lymphoma Evaluation Criteria
- No known or suspected central nervous system involvement by lymphoma
- Previous antineoplastic treatment completed at least 2 weeks or 5 drug half-lives prior
- Age 18 years or older
- ECOG score between 0 and 2
- Expected survival of 3 months or more
- Negative pregnancy test within 7 days before first dose for women of childbearing potential
- Agreement to use effective contraception during study and 6 months after last dose
- Ability to comply with study protocol
- Signed informed consent form
You will not qualify if you...
- Other malignancies within 5 years except certain treated skin and in situ carcinomas
- Previous autologous or allogeneic hematopoietic stem cell transplantation
- History of Richter transformation
- More than one line of systemic antineoplastic therapy received
- Prior treatment with PI3K inhibitors
- Known hypersensitivity to study drugs
- Active infections requiring treatment
- Need for prolonged systemic steroid or immunosuppressive therapy (inhaled or topical corticosteroids allowed)
- Conditions affecting oral medication intake or severe mental disorders
- Severe uncontrolled diseases including high blood pressure, significant heart conditions, lung disease, liver disease, renal failure requiring dialysis, uncontrolled effusions, or significant proteinuria
- Active or history of autoimmune diseases with risk of relapse (some stable hypothyroidism allowed)
- Known HIV infection or AIDS
- Positive pregnancy test or pregnancy
- Concurrent conditions compromising safety or study completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
W
Wei Liu, MD
CONTACT
L
Lugui Qiu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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