Peripheral T Cell LymphomaPhase 1NCT06712173
Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)
A Phase 1 study testing linperlisib and SHR2554 in people with Peripheral T Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This is a Phase I, multicenter, non-randomized, open-label, dose-exploratory clinical study to evaluate the safety and tolerability of linperlisib combined with SHR2554 in the treatment of R/R PTCL, and to preliminary observe the antitumor efficacy of the combination of the two drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- linperlisib and SHR2554
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Mar 2026
- Phase
- Phase 1
- 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
- Age ≥18 years old, male or female;
- Pathologically confirmed PTCL, including systemic anaplastic large cell lymphoma (ALCL), peripheral T cell lymphoma non-specific type (PTCL NOS), lymph node T-follicular helper cell lymphoma (nTFHL) [including nTFHL angioimmunoblastic type (NTFHL-AI), nTFHL follicular type (NTFHL-F) and nTFHL non-specific name (NTFHL-NOS)], enteropathy-associated T-cell lymphoma and hepato-splenic T-cell lymphoma;
- Have received at least one previous systemic therapy, ALCL patients must have received CD30-targeted therapy; Patients were allowed to have received hematopoietic stem cell transplantation;
- There must be at least one evaluable lesion/measurable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria [Evaluable lesion
- ECOG PS 0-2;
- Adequate organ function:
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- Expected survival of at least 3 months;
- Fertile male and female subjects are willing to use effective contraceptive measures throughout the study period and for six months after the last dose.
- Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.
Who cannot join
- If a patient has any of the following conditions should not be included in this study:
- Had been treated with PI3K inhibitor or EZH2 inhibitor or EZH1/2 inhibitor before enrollment;
- Primary cutaneous T-cell lymphoma;
- History of other primary aggressive malignancies that are not in remission or in remission for no more than 3 years;
- Involvement of the central nervous system (meninges or brain parenchyma);
- People with a known allergy to any of the drugs in the study
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- Participated in other drug clinical trials within 4 weeks before the study began;
- Pregnant or lactating women;
- Active infected persons, except tumor-related B symptom fever;
- Diseases and medical history:
- have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- have a history of psychotropic substance abuse and can not quit or have mental disorders;
- Subjects with any severe and/or uncontrolled medical condition;
- A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- Other situations deemed unsuitable for inclusion in the study by the researcher.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Arm, Open Label, Single-center Dose-exploratory Clinical Study of Linperlisib in Combination With EZH2 Inhibitor SHR2554 in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
This is a Phase I, multicenter, non-randomized, open-label, dose-exploratory clinical study to evaluate the safety and tolerability of linperlisib combined with SHR2554 in the treatment of R/R PTCL, and to preliminary observe the antitumor efficacy of the combination of the two drugs.
Read the detailed description
Linperlisib doses were preset at 40mg QD and 60mg QD, while SHR2554 doses were preset at 150mg BID, 200mg BID, and 300mg BID, forming six dose groups in total. The BOIN Waterfall design was employed to divide these six groups into two sub-trials.
Initially, three participants will be recruited into the lowest dose group of the first sub-trial: Linperlisib (40mg QD) and SHR2554 (150mg BID). After completing the dose-limiting toxicity (DLT) observation period, the next dose group will begin. Once DLT evaluations for the three participants are completed, the statistician will review the safety data and, following the decision-making flowchart of the BOIN design, determine whether to escalate to the next dose level. Another three participants will be enrolled and evaluated, continuing this process until all dose combinations in the first sub-trial have been tested, the sample size is depleted, or a stopping rule is triggered. Based on the results of the first sub-trial, the statistician will assess and select the starting dose for the second sub-trial, repeating the process until the trial is complete.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- linperlisib and SHR2554
- Keywords
- Peripheral T Cell Lymphoma, SHR2554, PI3K inhibitor linperlisib
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linperlisib and SHR2554Drug
Linperlisib doses were preset at 40mg QD and 60mg QD, while SHR2554 doses were preset at 150mg BID, 200mg BID, and 300mg BID, forming six dose groups in total.
| Study group | Role | What they receive |
|---|---|---|
| linperlisib combined with SHR2554 | Experimental | Not described Receives: Drug: linperlisib and SHR2554 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of linperlisib in combination with SHR2554
MTD will be established according to the incidence of dose-limiting toxicities (DLTs)
Measured: 28 days since the date of first dose
Secondary outcomes (5)
Safety of linperlisib in combination with SHR2554
The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of linperlisib in combination with SHR2554 will be assessed.
Measured: From the start of treatment until 30 days after the last treatment
Overall response rate (ORR)
Assess the response rate of subjects to the treatment of linperlisib in combination with SHR2554
Measured: 2 years
Complete response (CR) rate
Assess the complete response rate of subjects to the treatment of linperlisib in combination with SHR2554
Measured: 2 years
Progression-free survival (PFS)
Assess the survival condition of the subjects after the treatment of linperlisib in combination with SHR2554
Measured: 2 years
Overall survival (OS)
Assess the overall survival of subjects treated by linperlisib in combination with SHR2554
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712173
- Sponsor's protocol ID
- IIT2024029
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Single-center Dose-exploratory Clinical Study of Linperlisib in Combination With EZH2 Inhibitor SHR2554 in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06712173
- Acronym / sponsor ID
- IIT2024029
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- Peripheral T Cell Lymphoma, SHR2554, PI3K inhibitor linperlisib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 Dec 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.
This is a Phase I, multicenter, non-randomized, open-label, dose-exploratory clinical study to evaluate the safety and tolerability of linperlisib combined with SHR2554 in the treatment of R/R PTCL, and to preliminary observe the antitumor efficacy of the combination of the two drugs.
Detailed description
Linperlisib doses were preset at 40mg QD and 60mg QD, while SHR2554 doses were preset at 150mg BID, 200mg BID, and 300mg BID, forming six dose groups in total. The BOIN Waterfall design was employed to divide these six groups into two sub-trials.
Initially, three participants will be recruited into the lowest dose group of the first sub-trial: Linperlisib (40mg QD) and SHR2554 (150mg BID). After completing the dose-limiting toxicity (DLT) observation period, the next dose group will begin. Once DLT evaluations for the three participants are completed, the statistician will review the safety data and, following the decision-making flowchart of the BOIN design, determine whether to escalate to the next dose level. Another three participants will be enrolled and evaluated, continuing this process until all dose combinations in the first sub-trial have been tested, the sample size is depleted, or a stopping rule is triggered. Based on the results of the first sub-trial, the statistician will assess and select the starting dose for the second sub-trial, repeating the process until the trial is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| linperlisib combined with SHR2554 | Experimental | Drug: linperlisib and SHR2554 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years old, male or female;
- Pathologically confirmed PTCL, including systemic anaplastic large cell lymphoma (ALCL), peripheral T cell lymphoma non-specific type (PTCL NOS), lymph node T-follicular helper cell lymphoma (nTFHL) [including nTFHL angioimmunoblastic type (NTFHL-AI), nTFHL follicular type (NTFHL-F) and nTFHL non-specific name (NTFHL-NOS)], enteropathy-associated T-cell lymphoma and hepato-splenic T-cell lymphoma;
- Have received at least one previous systemic therapy, ALCL patients must have received CD30-targeted therapy; Patients were allowed to have received hematopoietic stem cell transplantation;
- There must be at least one evaluable lesion/measurable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria [Evaluable lesion
- ECOG PS 0-2;
Key exclusion criteria (15 listed)
- Had been treated with PI3K inhibitor or EZH2 inhibitor or EZH1/2 inhibitor before enrollment;
- Primary cutaneous T-cell lymphoma;
- History of other primary aggressive malignancies that are not in remission or in remission for no more than 3 years;
- Involvement of the central nervous system (meninges or brain parenchyma);
- People with a known allergy to any of the drugs in the study
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 and SHR2554Linperlisib doses were preset at 40mg QD and 60mg QD, while SHR2554 doses were preset at 150mg BID, 200mg BID, and 300mg BID, forming six dose groups in total. | Drug | linperlisib combined with SHR2554 |
Primary outcome
Maximum Tolerated Dose (MTD) of linperlisib in combination with SHR2554
Time frame: 28 days since the date of first dose
MTD will be established according to the incidence of dose-limiting toxicities (DLTs)
5 secondary outcomes
Safety of linperlisib in combination with SHR2554
Time frame: From the start of treatment until 30 days after the last treatment
Overall response rate (ORR)
Time frame: 2 years
Complete response (CR) rate
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 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 2 Dec 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing linperlisib and SHR2554 in people with Peripheral T Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, 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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Tingyu Wang (15692201678, wangtingyu@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of linperlisib in combination with SHR2554 (time frame: 28 days since the date of first dose). 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 2 Dec 2024.