Peripheral T/NK Cell Lymphoma (R/R PTCL)Phase 2NCT05274997
A Phase II Study of Linperlisib (YY-20394) in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
A Phase 2 study testing YY-20394 in people with Peripheral T/NK Cell Lymphoma (R/R PTCL), run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in United States.
Trial summary
This is a Phase II, single-arm study to evaluate the efficacy, safety, and PK of oral linperlisib (YY-20394) monotherapy in adult patients with R/R Peripheral T/NK Cell Lymphoma. The study will be conducted at approximately 15 sites in United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T/NK Cell Lymphoma (R/R PTCL)
- What is being tested?
- YY-20394
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Adult patient ≥18 years of age at the time of signing the informed consent.
- Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the WHO 2017 classification system:
- Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS)
- Angioimmunoblastic T-cell lymphomas (AITL)
- Anaplastic large cell lymphoma (ALCL). ALK positive or ALK negative
- Natural-killer/T-cell lymphoma (NKTCL)
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- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL).
- Has received and failed at least one line of systemic therapy.
- Not a candidate for autologous or allogeneic transplantation.
- For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin.
- Agree to provide archived tumor tissue samples or undergo pretreatment fresh tissue biopsy.
- Has radiographically measurable disease as per Lugano Criteria with at least one measurable disease lesion > 1.5 cm in at least one dimension (which has not been previous radiated) by 18FDG-PET-CT, MRI, or diagnostic CT within 28 days prior to start of study treatment.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has adequate organ function as defined below:
- System Laboratory Value Haematological Absolute neutrophil count
- 1.0×109/L Note: No growth factor supports within 14 days of first dose Platelet count
- 75×109/L Note: ≥50 × 109/L for patients with bone marrow infiltration No blood product transfusion is allowed within 14 days of first dose. Haemoglobin
- 8.0 g/L Note: criteria must be met without erythropoietin dependency and no blood product transfusion is allowed within 14 days of first dose Hepatic Total bilirubin
- 1.5×ULN Note: Patients with Gilbert's Syndrome or other benign congenital hyperbilirubinemia may be eligible at the Investigator's discretion in consultation with the Medical Monitor, if ≤ 3 × ULN Alanine aminotransferase
- 2.5×ULN Note: ≤ 5 × ULN if there is liver involvement by lymphoma Aspartate aminotransferase
- 2.5×ULN Note: ≤ 5 × ULN if there is liver involvement by lymphoma Renal CrCl calculated by Cockcroft-Gault formula CrCl ≥50 mL/min Coagulation INR < 1.5 without anti-coagulation therapy Activated partial thromboplastin time aPTT ≤1.5 ULN Cardiac Left ventricular ejection fraction LVEF ≥ 50% by an echocardiogram (ECHO) or multigated acquisition scan (MUGA). QTcF <470 ms Abbreviations: CrCl=creatinine clearance; RBC=red blood cell; QTcF=QT interval corrected using Fridericia's formula; ULN=upper limit of normal.
- Male patients are eligible to participate if they agree to use a highly effective contraception as detailed in Appendix 4 of this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period. 11. Female patients are eligible to participate if they are not pregnant (see Appendix 4), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR
- A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle as described in Appendix 4, beginning the time of informed consent, during the treatment period and for at least 3 months after the last dose of study treatment.
- A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment.
- 12. Patient is capable of giving signed informed consent. 13. Must be willing and able to adhere to the study and lifestyle restrictions as judged by the investigator.
Who cannot join
- 1. Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma).
- 2. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication, any other cardiac disorder not suitable for participation in this study based on the judgment of the investigator. Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
- 3. Presence of multiple factors affecting drug administration and absorption such as inability to swallow, diarrhea of CTCAE Grade >1, and ileus.
- 4. Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
- 5. Prior history of drug-induced colitis or drug-induced pneumonitis. 6. Has active viral, bacterial, fungal infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment. Routine antimicrobial prophylaxis is permitted.
- 7. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.
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- 8. Use of therapeutic doses of warfarin sodium (Coumadin), or any other coumarin-derivative anticoagulants. The administration of low-molecular weight heparin is allowed.
- 9. Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE version 5.0 grade 0 or 1 with the exception of alopecia and peripheral neuropathy.
- 10. Medical history of other primary malignant tumors in the past 5 years, or any evidence of residual disease from a previously diagnosed malignancy. Note: Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast, cervical cancer in situ, superficial bladder tumors [Ta and Tis; carcinoma in situ]) who have undergone curative therapy with no evidence of recurrence, localized prostate cancer previously fully resected undergoing surveillance or other adequately treated Stage 1 cancer currently in complete remission.
- 11. Has received prior treatment with linperlisib (YY-20394), or other PIK3-δ inhibitors. Patients who have received prior treatment with other PIK3-δ inhibitors, but were intolerant to them, maybe included.
- 12. Has received prior treatment with rituximab or other unconjugated antibody treatment within 28 days (21 days if clear evidence of progressive disease or immediate treatment is mandated) prior to the first dose of study treatment.
- 13. Has received radioimmunoconjugates or toxin conjugates within 12 weeks before the first dose of study treatment.
- 14. Has had received prior systemic anticancer therapy, or definitive radiotherapy ≤28 days (14 days for palliative radiation) prior to the first dose of study treatment.
- 15. Has received prior targeted small molecule therapy ≤14 days or 5 half-lives whichever is longer.
- 16. Has undergone major surgery (excluding lymph node biopsy) or significant trauma ≤4 weeks before the first dose of study treatment. Note: patients must have recovered adequately from surgery prior to starting study treatment.
- 17. Use of medications or foods that are strong cytochrome CYP3A inhibitors, strong CYP3A inducers within 14 days prior to first dose of study treatment or 5 half-lives of the given drug, whichever is longer.
- 18. Use of any drug that may result in QT prolongation (e.g., antiarrhythmic agents) cannot be interrupted during the study.
- 19. Has a history of immunodeficiency or autoimmune disease has received systemic steroids (in dosing exceeding 10 mg daily of prednisolone equivalent) or any other form of immunosuppressive therapy within 7 days of the first dose of study treatment. The use of physiological doses of corticosteroids may be approved after consultation with the Medical Monitor.
- 20. Has received a live vaccination within 30 days before the first dose of study treatment or is scheduled to be administered during the study period. Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, varicella/zoster, yellow fever, Bacille Calmette-Guérin (BCG) and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- 21. Human immunodeficiency virus (HIV) infection with a current or a known history of acquired immunodeficiency syndrome (AIDS)-defining illness or HIV infection with a CD4+ T cell count <350 cells/μL and an HIV viral load more than 400 copies/μL.
- 22. Patients with active viral (any etiology) hepatitis are excluded. Patients with a history of hepatitis C virus (HCV) infection who have completed curative antiviral treatment and have a viral load below the limit of quantification may be eligible and should be discussed with the Medical Monitor.
- 23. Patients who have a positive PCR test for CMV at screening will not be enrolled in the study.
- 24. Has a history or current evidence of any condition, laboratory abnormality or other circumstances that might confound the results of the study or interfere with participation for the full duration of the study, such that it is not in the best interests of the patient to take part in the study.
- 25. Patient is pregnant or breastfeeding or expecting to conceive of father children for the duration of the study.
- 26. Has a history of hypersensitivity to linperlisib (YY-20394) and/or any excipients.
- 27. Has a known psychiatric disorder that would interfere with compliance with the requirements of the study.
- 28. Is a regular user of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Ranjit C Nair, MD,
Swaminathan Padmanabhan Iyer, ajaickareth@mdanderson.org
About this study
Official title: A Single-arm, Phase II Study to Evaluate the Efficacy and Safety of Linperlisib (YY-20394) Monotherapy in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
This is a Phase II, single-arm study to evaluate the efficacy, safety, and PK of oral linperlisib (YY-20394) monotherapy in adult patients with R/R Peripheral T/NK Cell Lymphoma. The study will be conducted at approximately 15 sites in United States.
- Conditions
- Peripheral T/NK Cell Lymphoma (R/R PTCL)
- Being tested
- YY-20394
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-20394Drug
Also called Linperlisib
Linperlisib is a strong and selective small-molecule PI3K-δ (a protein involves in the survival of cells) inhibitor, which is able to interfere with the growth, migration and survival of T/NK lymphoma cells.
| Study group | Role | What they receive |
|---|---|---|
| YY-20394 | Experimental | Administer linperlisib (YY-20394) 80 mg (4 tablets) orally with water, once daily, in a 28-day cycle. Receives: Drug: YY-20394 |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
Overall response rate (ORR = CR + PR), from start of treatment to first documented response, measured by Lugano 2014 Response Criteria for NHL (Cheson 2014)
Measured: Throughout the study for approximately 2 years
Secondary outcomes (11)
duration of response (DOR)
DOR, defined as time from first documentation of a response (PR or CR) to the first documented disease progression or death due to any cause, whichever occurs first, for those patients with a PR or CR.
Measured: Throughout the study for approximately 2 years
progression-free survival (PFS),
PFS, defined as the time from start of treatment to first documented disease progression or death due to any cause, whichever occurs first.
Measured: Throughout the study for approximately 2 years
Overall survival (OS)
Measured: Throughout the study for approximately 2 years
Time to response (TTR)
Measured: Throughout the study for approximately 2 years
AE
Incidence of Adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Measured: Throughout the study for approximately 2 years
AUClast
PK parameters
Measured: Throughout the study for approximately 2 years
AUCinf
PK parameters
Measured: Throughout the study for approximately 2 years
Cmin
PK parameters
Measured: Throughout the study for approximately 2 years
Cmax
PK parameters
Measured: Throughout the study for approximately 2 years
T1/2
PK parameters
Measured: Throughout the study for approximately 2 years
Tmax
PK parameters
Measured: Throughout the study for approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 May 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T/NK Cell Lymphoma (R/R PTCL)Studies of the same condition, open and under way.
- 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
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ranjit Nair, MD., Principal investigator, MD Anderson, Houston TX 77030 Study Chair: Swaminathan P Iyer MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274997
- Sponsor's protocol ID
- YY-20394-012
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Phase II Study to Evaluate the Efficacy and Safety of Linperlisib (YY-20394) Monotherapy in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05274997
- Acronym / sponsor ID
- YY-20394-012
- Conditions
- Peripheral T/NK Cell Lymphoma (R/R PTCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 11 Mar 2022 (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 II, single-arm study to evaluate the efficacy, safety, and PK of oral linperlisib (YY-20394) monotherapy in adult patients with R/R Peripheral T/NK Cell Lymphoma. The study will be conducted at approximately 15 sites in United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YY-20394 | Experimental | Drug: YY-20394Administer linperlisib (YY-20394) 80 mg (4 tablets) orally with water, once daily, in a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Adult patient ≥18 years of age at the time of signing the informed consent.
- Diagnosis of one of the following histologic subtypes of PTCL, pathologically confirmed, as defined by the WHO 2017 classification system:
- Has received and failed at least one line of systemic therapy.
- Not a candidate for autologous or allogeneic transplantation.
- For patients with CD30+ PTCL, progressed on or are ineligible or intolerant to brentuximab vedotin.
Key exclusion criteria (27 listed)
- 1. Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma).
- 2. Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication, any other cardiac disorder not suitable for participation in this study based on the judgment of the investigator. Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
- 3. Presence of multiple factors affecting drug administration and absorption such as inability to swallow, diarrhea of CTCAE Grade >1, and ileus.
- 4. Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
- 5. Prior history of drug-induced colitis or drug-induced pneumonitis. 6. Has active viral, bacterial, fungal infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment. Routine antimicrobial prophylaxis is permitted.
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 |
|---|---|---|
| YY-20394Also: LinperlisibLinperlisib is a strong and selective small-molecule PI3K-δ (a protein involves in the survival of cells) inhibitor, which is able to interfere with the growth, migration and survival of T/NK lymphoma cells. | Drug | YY-20394 |
Primary outcome
overall response rate (ORR)
Time frame: Throughout the study for approximately 2 years
Overall response rate (ORR = CR + PR), from start of treatment to first documented response, measured by Lugano 2014 Response Criteria for NHL (Cheson 2014)
11 secondary outcomes
duration of response (DOR)
Time frame: Throughout the study for approximately 2 years
progression-free survival (PFS),
Time frame: Throughout the study for approximately 2 years
Overall survival (OS)
Time frame: Throughout the study for approximately 2 years
Time to response (TTR)
Time frame: Throughout the study for approximately 2 years
AE
Time frame: Throughout the study for approximately 2 years
AUClast
Time frame: Throughout the study for approximately 2 years
AUCinf
Time frame: Throughout the study for approximately 2 years
Cmin
Time frame: Throughout the study for approximately 2 years
Cmax
Time frame: Throughout the study for approximately 2 years
T1/2
Time frame: Throughout the study for approximately 2 years
Tmax
Time frame: Throughout the study for approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 1
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
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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. This study is not recruiting at the moment.
Ranjit Nair, MD. principal investigator
MD Anderson, Houston TX 77030 Study Chair: Swaminathan P Iyer MD
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 YY-20394 in people with Peripheral T/NK Cell Lymphoma (R/R PTCL), run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in United States.
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 26 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meiyue Hong (+862151370693, myhong@yl-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (ORR) (time frame: Throughout the study for approximately 2 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 21 Oct 2022.