Actively Recruiting
Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas: An Open, Prospective Trial
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-12
51
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of PI3K inhibitors for treating relapsed or refractory indolent T/NK-cell lymphomas, a group of slow-growing but currently incurable blood cancers originating from T or NK cells. This open-label, prospective clinical trial aims to assess the feasibility, effectiveness, and safety of these treatments in patients whose disease has not responded to first-line therapies and who have limited options. Participants will receive one of two PI3K inhibitor drugs: Linperlisib at 80mg once daily orally or Duvelisib at 25mg twice daily orally, given in 28-day cycles. Treatment will continue for up to 24 cycles unless the disease progresses, there is no response within the first six cycles, or intolerable side effects occur. Effectiveness will be assessed after each cycle during the first year, then every two cycles thereafter. During the study, patients will undergo regular evaluations including response assessments to measure overall response rate, safety monitoring, and other outcomes such as complete remission rate and progression-free survival, tracked for up to five years. The study involves ongoing monitoring for treatment effects and safety to better understand these drugs’ impact on this patient population.
CONDITIONS
Brief Title
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with relapsed or refractory indolent T/NK-cell lymphomas
- Tumors that have not progressed after treatment over a specific period, including complete response, partial response, or stable disease
You will not qualify if you...
- Previous use of any PI3K inhibitors
- Conditions affecting swallowing, absorption, or gastrointestinal health that could impact study drug intake
- Inability to stop medications that prolong the QT interval during the study
- Active infections requiring treatment, such as pneumonia
- Hepatitis B or C infection or active hepatitis
- History of immunodeficiency or prior organ or stem cell transplantation
- Autologous stem cell transplant within 90 days before starting study treatment
- Severe or uncontrolled heart disease
- Serious diseases affecting safety or study completion, including uncontrolled hypertension, diabetes, or thyroid disease
- Pregnant or breastfeeding women, or positive pregnancy test
- Diagnosis or treatment for other cancers within the past 5 years
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles (28-day cycles)
Participants receive PI3K inhibitor treatment orally in 28-day cycles. Treatment continues for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or intolerable toxicity.
1 visit per cycle during the first year, then 1 visit every two cycles thereafter
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
S
Shuhua Yi, Doctor
L
Lugui Qiu, Doctor
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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