Actively Recruiting
Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)
Led by Peking University · Updated on 2024-04-04
54
Participants Needed
1
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is conducted to evaluate the efficacy and safety of linperlisib combined with CHOP regimen followed by autologous hematopoietic stem cell transplantation and linperlisib monotherapy maintenance for newly diagnosed nTFHL patients.
CONDITIONS
Official Title
Linperlisib-based Treatment Regimen in Newly Diagnosed Nodal T-follicular Helper Cell Lymphoma (nTFHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed nodal T-follicular helper cell lymphoma (nTFHL) classified by WHO-HAEM5, including angioimmunoblastic-type, follicular-type, or NOS
- Planning to receive autologous hematopoietic stem cell transplantation
- No previous systemic treatment before enrollment
- At least one measurable lesion with lymph node diameter >1.5 cm or extra lymph node lesion >1 cm
- Aged 18 to 65 years, any gender
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Expected survival time of at least 12 weeks
- Adequate bone marrow and organ function with negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during study and for 6 months after last dose
- Adequate organ and bone marrow function without severe abnormalities or recent blood transfusion/support
- Voluntary participation with signed informed consent and ability to complete all trial procedures
You will not qualify if you...
- Known allergy to linperlisib or CHOP regimen ingredients
- Conditions affecting oral medication intake such as swallowing difficulties, chronic diarrhea, or intestinal obstruction
- Active, known, or suspected autoimmune disease requiring systemic immunosuppressive therapy
- History of interstitial pneumonia
- Other malignancies within 2 years except certain treated skin, thyroid, breast, or cervical carcinomas in situ
- Received systemic antitumor therapy within 28 days before enrollment
- Previous autologous or allogeneic hematopoietic stem cell transplantation
- Active tuberculosis
- Severe infections needing systemic treatment
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Poorly controlled diabetes (fasting blood glucose >10 mmol/L)
- Heart failure Class III or IV, uncontrolled coronary disease or arrhythmia, recent myocardial infarction
- Clinically significant bleeding or bleeding tendency within 3 months
- Renal failure requiring dialysis
- Significant urinary protein abnormalities
- Recent major surgery or severe trauma within 28 days
- Complicated interstitial lung disease or severely impaired lung function
- Need for systemic corticosteroids (>10 mg prednisone/day) or immunosuppressants within 14 days prior to study drug
- Known HIV infection
- Active hepatitis B or C infection with elevated liver enzymes or co-infection
- Any condition that may interfere with study results or judged inappropriate by investigators
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bejing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
P
PING WEI LIU, Master
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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