Non-Hodgkin LymphomaPhase 2NCT07195799
Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in R/R NHL
A Phase 2 study testing Linperlisib combined with CPT regimen in people with Non-Hodgkin Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a multicenter, open-label, non-randomized, multi-cohort study to evaluate the efficacy and safety of linperlisib combined with cyclophosphamide, prednisone, and thalidomide (CPT) regimen in the treatment of relapsed and/or refractory non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Linperlisib combined with CPT regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2027
- 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
- Male or female, ≥18 years old;
- Histologically confirmed diagnosis of FL/PTCL/NKTCL/CLL /MZL/MCL;
- Except for CLL (using the 2018 iwCLL criteria), patients must have at least one measurable lesion/evaluable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria;
- FL patients:
- Should be relapsed after second-line or more systemic therapy (CD20 monoclonal antibody and at least one alkylating agent, including but not limited to bendamustine, fludarabine, cyclophosphamide, isocyclophosphamide, etc.); 5. PTCL patients:
- Have previously received at least one-line systemic treatment, have disease progression during or after the most recent treatment, or confirmed no objective response with adequate treatment;
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- Includes the following subtypes: PTCL-NOS, AITL, ALK+ALCL, ALK-ALCL，EATL; patients with ALCL must have previously received CD30-targeted therapy or be ineligible for CD30-targeted therapy; 6. NK/TCL patients:
- 1) Have previously received at least one line systemic treatment, have disease progression during or after the most recent treatment, or have confirmed no objective response with adequate treatment; 2) Have previously received a regimen containing Pegaspargase or L-Pegaspargase; 7. CLL patients:
- Have measurable lesions (peripheral blood B lymphocytes ≥5×10^9/L, or enlarged lymph node (baseline LDi ≥ 1.5cm), or hepatomegaly or splenomegaly due to CLL);
- Patients with resistance or intolerance following prior first-line or above therapy (regiments containing BTK inhibitors or BCL-2 inhibitors);
- Treatment should be initiated when at least one indication for treatment according to IWCLL guideline are present; 8. MZL patients: Should have previously received at least two-line systemic therapy containing CD20 monoclonal antibodies and have not achieved at least partial response (PR) after recent systemic therapy, or have confirmed disease progression after treatment, and investigators judge that effective and standard treatment options are lacking; 9. MCL patients:
- Previous second-line or higher treatment regimen including:
- at least first-line immunotherapy or chemical immunotherapy containing anti-CD20 monoclonal antibody; Or anti-CD20 mab combined with BTK inhibitors;
- have been treated with at least one appropriate BTK inhibitor and BCL-2 inhibitor (monotherapy or in combination with other antineoplastic agents); 10. ECOG PS: 0~2; 11. Expected survival ≥ 3 months; 12. Good organ function; 13. The washout period from the end of any previous antineoplastic therapy, including radiation therapy, chemotherapy, hormone therapy, surgery, or molecular-targeted therapy until participate in the trial should be at least 28 days or five half-life of the drug, whichever was shorter; 14. Fertile male and female subjects are willing to use effective contraceptive measures throughout the study period and for six months after the last dose; 15. Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.
Who cannot join
- Patients with any of the following conditions are not eligible to participate in this study:
- Had been progressed on PI3K inhibitor before enrollment;
- Any other anti-tumor therapy within 4 weeks;
- The presence of third-space effusion (e.g., massive pleural effusion and ascites) that could not be controlled by drainage or other methods;
- Involvement of the central nervous system (meninges or brain parenchyma);
- Long-term use of corticosteroids exceeding 30mg/day of prednisone or its equivalent;
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- Inability to swallow, chronic diarrhea or intestinal obstruction, or other factors affecting drug intake and absorption;
- Individuals with a history of allergies or known hypersensitivity to any component of the regimen;
- A history of any cardiac disease, including: (1) angina; (2) arrhythmias requiring clinical intervention; (3) myocardial infarction; (4) heart failure; (5) any other cardiac conditions deemed unsuitable for participation in this trial by the investigator;
- Active viral, bacterial, or fungal infections requiring treatment (such as pneumonia);
- Uncontrolled diabetes, pulmonary fibrosis, acute lung disease, interstitial lung disease, or liver failure;
- Individuals with HBV or HCV infection (defined as positive for HbsAg and/or HbcAb with detectable HBV DNA copies) or positive for active hepatitis C (HCV) antibodies;
- A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
- Received autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
- Could not receive preventive treatment for pneumocystis, HSV, or HZV at screening;
- Major surgery within 2 weeks before starting treatment;
- Any adverse event related to prior treatment, but has not recovered to grade ≤ 1;
- Existing active bleeding or new thrombotic disease, or have a history of bleeding tendency;
- Pregnant or breastfeeding female patients, or women of childbearing potential with a positive baseline pregnancy test;
- Concomitant diseases (such as severe hypertension, diabetes, thyroid disease, etc.);
- Other malignancies within the last 5 years, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Received live attenuated vaccines within 30 days prior to the first dose;
- Histologically or cytologically confirmed patients with grade 3b follicular lymphoma, and known follicular lymphoma transformed into diffuse large B-cell lymphoma;
- T-cell lymphoma and NK/T-cell lymphoma with hemophagocytic syndrome;
- Other situations deemed unsuitable for inclusion in the study by the researcher.
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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Huayuan ZHU, MD, phD, +86-13813810650, huayuan.zhu@hotmail.com
Huayuan ZHU, MD, phD
About this study
Official title: A Multicenter Prospective Study of Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in Relapsed and/or Refractory Non-Hodgkin Lymphoma
This is a multicenter, open-label, non-randomized, multi-cohort study to evaluate the efficacy and safety of linperlisib combined with cyclophosphamide, prednisone, and thalidomide (CPT) regimen in the treatment of relapsed and/or refractory non-Hodgkin lymphoma.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Linperlisib combined with CPT regimen
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linperlisib combined with CPT regimenDrug
Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.
Linperlisib combined with CPT regimenDrug
Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.
Linperlisib combined with CPT regimenDrug
Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.
Linperlisib combined with CPT regimenDrug
Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.
Linperlisib combined with CPT regimenDrug
Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.
Linperlisib combined with CPT regimenDrug
Linperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first.
| Study group | Role | What they receive |
|---|---|---|
| PTCL | Experimental | Not described Receives: Drug: Linperlisib combined with CPT regimen |
| NK/TCL | Experimental | Not described Receives: Drug: Linperlisib combined with CPT regimen |
| CLL | Experimental | Not described Receives: Drug: Linperlisib combined with CPT regimen |
| MZL | Experimental | Not described Receives: Drug: Linperlisib combined with CPT regimen |
| MCL | Experimental | Not described Receives: Drug: Linperlisib combined with CPT regimen |
| FL | Experimental | Not described Receives: Drug: Linperlisib combined with CPT regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Objective Response Rate
The rate of best overall response is the proportion of patients who achieve their best recorded response (complete or partial) to treatment at any time during the study.
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Secondary outcomes (7)
Complete remission rate
Overall response rate is the proportion of patients who achieve a complete response to treatment defined by the Lugano classification criteria for lymphoma response evaluation (2014 edition).
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Disease control rate
Disease control rate is the proportion of patients who achieve either a complete or partial response to treatment defined by the Lugano classification criteria for lymphoma response evaluation (2014 edition).
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Duration of Response
Duration of response is the duration from the first documentation of a complete or partial response to disease progression or death.
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Time To Response
Time to response is the duration from the start of treatment to the first documentation of a complete or partial response.
Measured: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Progression-free survival
PFS is defined as the time from the first dose of treatment to progression, or death due to any cause, whichever occurs first. For subjects without progression, relapse, or death at the time of analysis, EFS will be censored at the last assessment date.
Measured: From the first dose of treatment until the date of progression or date of death from any cause, whichever came first.
Overall survival
OS is defined as the time from the first dose of treatment to death due to any cause. Subjects who remain alive at the time of analysis will be censored at the last known alive date of the subject.
Measured: From the first dose of treatment until the date of death from any cause
Number of participants with any adverse events (Safety assessed by NCI-CTC AE v5.0)
All treatment-emergent AEs will be included in the analysis. For each AE, the number and percentage of subjects who experience at least one occurrence of the given event will be summarized. The number and percent of subjects with TEAEs will be summarized according to intensity (CTCAE, v5) for hematologic toxicity, and drug relationship, as well as categorized by system organ class and preferred term. Summaries, listings, datasets, or subject narratives may be provided, as appropriate, for those subjects who die, who discontinue treatment due to an AE, or who experience a severe AE or a SAE.
Measured: Safety was evaluated everyday during induction and maintenance therapy. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start31 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195799
- Sponsor's protocol ID
- 2024-SR-219
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Linperlisib Combination With Cyclophosphamide, Prednisone, and Thalidomide (CPT) in Relapsed and/or Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07195799
- Acronym / sponsor ID
- 2024-SR-219
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (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.
This is a multicenter, open-label, non-randomized, multi-cohort study to evaluate the efficacy and safety of linperlisib combined with cyclophosphamide, prednisone, and thalidomide (CPT) regimen in the treatment of relapsed and/or refractory non-Hodgkin lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PTCL | Experimental | Drug: Linperlisib combined with CPT regimen |
| NK/TCL | Experimental | Drug: Linperlisib combined with CPT regimen |
| CLL | Experimental | Drug: Linperlisib combined with CPT regimen |
| MZL | Experimental | Drug: Linperlisib combined with CPT regimen |
| MCL | Experimental | Drug: Linperlisib combined with CPT regimen |
| FL | Experimental | Drug: Linperlisib combined with CPT regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, ≥18 years old;
- Histologically confirmed diagnosis of FL/PTCL/NKTCL/CLL /MZL/MCL;
- Except for CLL (using the 2018 iwCLL criteria), patients must have at least one measurable lesion/evaluable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria;
- FL patients:
- Should be relapsed after second-line or more systemic therapy (CD20 monoclonal antibody and at least one alkylating agent, including but not limited to bendamustine, fludarabine, cyclophosphamide, isocyclophosphamide, etc.); 5. PTCL patients:
Key exclusion criteria (25 listed)
- Patients with any of the following conditions are not eligible to participate in this study:
- Had been progressed on PI3K inhibitor before enrollment;
- Any other anti-tumor therapy within 4 weeks;
- The presence of third-space effusion (e.g., massive pleural effusion and ascites) that could not be controlled by drainage or other methods;
- Involvement of the central nervous system (meninges or brain parenchyma);
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 |
|---|---|---|
| Linperlisib combined with CPT regimenLinperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first. | Drug | CLL |
| Linperlisib combined with CPT regimenLinperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first. | Drug | FL |
| Linperlisib combined with CPT regimenLinperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first. | Drug | MCL |
| Linperlisib combined with CPT regimenLinperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first. | Drug | MZL |
| Linperlisib combined with CPT regimenLinperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first. | Drug | NK/TCL |
| Linperlisib combined with CPT regimenLinperlisib: 80mg QD during the cycle 1-2，80mg QD for the first 7 days of cycle 3-6 (each cycle is 28 days) Cyclophosphamide: 50mg QD during the cycle 1-6 (each cycle is 28 days) Prednisone: 20mg QD during the cycle 1-6 (each cycle is 28 days) Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days) After six cycles, patients with CR or PR continue to receive linperlisib at a dose of 80mg for the first 7 days every cycle (each cycle is 28 days) until disease progression, intolerable toxicity, investigator judgment that treatment should be discontinued, or subject withdrawal of consent, whichever occurred first. | Drug | PTCL |
Primary outcome
Best Objective Response Rate
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
The rate of best overall response is the proportion of patients who achieve their best recorded response (complete or partial) to treatment at any time during the study.
7 secondary outcomes
Complete remission rate
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Disease control rate
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Duration of Response
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Time To Response
Time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)
Progression-free survival
Time frame: From the first dose of treatment until the date of progression or date of death from any cause, whichever came first.
Overall survival
Time frame: From the first dose of treatment until the date of death from any cause
Number of participants with any adverse events (Safety assessed by NCI-CTC AE v5.0)
Time frame: Safety was evaluated everyday during induction and maintenance therapy. From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 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 29 Sep 2025.
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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.
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 Linperlisib combined with CPT regimen in people with Non-Hodgkin Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 14 inclusion and 25 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 29 Sep 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 Huayuan ZHU, MD, phD (+86-13813810650, huayuan.zhu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Objective Response Rate (time frame: On Day 1 of Cycle 4, Day 1 of Cycle 7, Day 1 of Cycle 10, Day 1 of Cycle 13, Day 1 of Cycle 16, Day 1 of Cycle 19, Day 1 of Cycle 22, and Day 1 of Cycle 25 (each cycle is 28 days)). 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 29 Sep 2025.