Actively Recruiting
Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma
Led by Sun Yat-sen University · Updated on 2024-05-17
50
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
CONDITIONS
Official Title
Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed peripheral T-cell lymphoma including PTCL NOS, angioimmunoblastic T-cell lymphoma, enteropathy related T-cell lymphoma, or liver spleen T-cell lymphoma
- No prior anti-tumor treatment
- At least one measurable or evaluable lesion by 2014 Lugano Lymphoma Evaluation Criteria
- Age 18 years or older
- ECOG performance status 0 to 2
- Expected survival longer than 3 months
- Adequate bone marrow and organ function
- Not accompanied by hemophagocytic syndrome or treated and evaluated as suitable
- Willing to participate and able to complete all study procedures with signed informed consent
You will not qualify if you...
- Previous treatment with PI3K inhibitors
- History of other invasive cancers not relieved for over 3 years
- Central nervous system involvement
- Known allergies to study medications
- Participation in other drug trials within 4 weeks prior to study
- Pregnant or breastfeeding women
- Active infections (except fever from tumor symptoms)
- Conditions affecting oral medication intake such as inability to swallow, chronic diarrhea, or bowel obstruction
- History of psychotropic substance abuse or mental disorders preventing participation
- Severe or uncontrolled diseases including poorly controlled blood pressure, serious heart conditions, active interstitial lung diseases, significant liver disease, renal failure needing dialysis, uncontrolled fluid buildup requiring drainage, poorly controlled diabetes, or significant proteinuria
- Immune deficiency disorders including HIV/AIDS or history of organ transplantation
- Serious accompanying diseases that threaten safety or affect ability to complete the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qingqing Cai, MD. PhD.
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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