Lymphoma, T-CellPhase 2NCT06530550
PI3K Inhibitors for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
A Phase 2 study testing PI3K inhibitor in people with Lymphoma, T-Cell and NK-LGL Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia
- What is being tested?
- PI3K inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2024to 10 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
Who cannot join
- Here is the translated text:
- Subjects who have previously used any PI3K inhibitors;
- Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
- Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- HBV or HCV infection (defined as HBsAg and/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;
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- History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or history of allogeneic bone marrow or hematopoietic stem cell transplantation;
- Received autologous hematopoietic stem cell transplantation within 90 days before the first dose of study treatment;
- Presence of severe or uncontrolled cardiovascular disease;
- Presence of severe concomitant diseases that endanger patient safety or are deemed by the investigator to affect the completion of the study (e.g., uncontrolled hypertension, diabetes, thyroid disease);
- Pregnant or breastfeeding female patients, or baseline pregnancy test positive for women of childbearing potential;
- Diagnosed or treated for other malignancies within the past 5 years;
- Any other condition that the investigator deems unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Shuhua Yi, Dr., 86-022-23909106, yishuhua@ihcams.ac.cn
Lugui Qiu, Dr., 86-022-23909286, qiulg@ihcams.ac.cn
About this study
Official title: Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.
Read the detailed description
Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive PI3K inhibitor treatment (including Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first
- Conditions
- Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia
- Being tested
- PI3K inhibitor
- Keywords
- Indolent T/NK-cell lymphomas, PI3K inhibitor
- Medical subject headings
- Lymphoma, T-Cell, Leukemia, Large Granular Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PI3K inhibitorDrug
Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| PI3K inhibitor | Experimental | Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally Receives: Drug: PI3K inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
complete remission rate+ partial remission rate
Measured: up to 5 years
Secondary outcomes (7)
The safety of PI3K inhibitors
Incidence of adverse events, serious adverse events and significant adverse event
Measured: up to 5 years
Complete remession rate
Hematological PR was defined as an improvement in blood counts ANC > 0.5 × 109/L; HGB increased by >1 g/dL; PLT > 50 × 109/L
Measured: up to 5 years
Duration of remission
the time from response to progression/death (P/D)
Measured: up to 5 years
Time to response
from the start of treatment to the first observed partial remission
Measured: up to 5 years
Progression-free survival
the time from treatment initiation until disease progression or death
Measured: up to 5 years
Overall survival
The time from the start of treatment to the patient's death from any cause
Measured: up to 5 years
Disease control rate
the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start10 Aug 2024
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-CellStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Yi, Doctor, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530550
- Sponsor's protocol ID
- IIT2024026
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of PI3K Inhibitors in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06530550
- Acronym / sponsor ID
- IIT2024026
- Conditions
- Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia
- Keywords
- Indolent T/NK-cell lymphomas, PI3K inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Linperlisib or Duvelisib, with an expected overall response rate of 60% for PI3K inhibitor treatment.
Detailed description
Plan to enroll 51 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive PI3K inhibitor treatment (including Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PI3K inhibitor | Experimental | Drug: PI3K inhibitorLinperlisib 80mg QD orally, or Duvelisib 25mg BID orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
Key exclusion criteria (13 listed)
- Subjects who have previously used any PI3K inhibitors;
- Clinical conditions of dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- Unable to discontinue medications that may prolong the QT interval (such as antiarrhythmic drugs) during the study period;
- Active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- HBV or HCV infection (defined as HBsAg and/or HBcAb positive with HBV DNA copy number ≥ upper limit of normal reference value) or acute or chronic active hepatitis C (HCV) antibody positive;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PI3K inhibitorLinperlisib 80mg QD orally, or Duvelisib 25mg BID orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first | Drug | PI3K inhibitor |
Primary outcome
Overall response rate
Time frame: up to 5 years
complete remission rate+ partial remission rate
7 secondary outcomes
The safety of PI3K inhibitors
Time frame: up to 5 years
Complete remession rate
Time frame: up to 5 years
Duration of remission
Time frame: up to 5 years
Time to response
Time frame: up to 5 years
Progression-free survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
Disease control rate
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuhua Yi, Doctor principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PI3K inhibitor in people with Lymphoma, T-Cell and NK-LGL Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuhua Yi, Doctor (86-22-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.