PTCLPhase 2NCT04705090
A Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
A Phase 2 study testing YY-20394 treatment in people with PTCL, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T/NK cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTCL
- What is being tested?
- YY-20394 treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jun 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
- Males and/or females over age 18.
- Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T/NK cell lymphoma.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to Lugano 2014.
- Adequate organ function.
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- Had anti-tumor treatment within 2 weeks prior to the first dose of investigational product (including TKI, Chinese herbal anti-tumor treatment); within 4 weeks prior to the first dose of investigational product (including chemotherapy, radiotherapy, immunotherapy and major surgery); other targeted therapies with 5 half-life period prior to the first dose.
- Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose.
- Volunteers did not participate in other clinical trials within 1 month prior to study entry.
- Provision of signed and dated, written informed consent prior to any study- specific evaluation.
Who cannot join
- Previous treatment with any PI3K-delta inhibitors.
- Uncontrolled pleural effusion and ascites.
- The dosage of steroid hormone (prednisone equivalent) was greater than 20mg/day, and lasted for more than 14 days.
- Medical conditions in swallowing difficulty, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/ or absorption of the investigational agent.
- Drugs that may prolong the QT (such as anti-arrhythmic drugs) could not be interrupted during the study period.
- Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression.
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- Have active viral, bacterial, fungal, or other infections that require systematic treatment (e.g., active tuberculosis), excluding nail bed fungal infections.
- Active infection with hepatitis B and C virus (volunteers with HBsAg or HBcAb positive but HBV-DNA negative, or HCV antibody positive but HCV-RNA negative can be enrolled).
- History of immune deficiency (acquired and congenital), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation; with active autoimmune disease or history of autoimmune disease (e.g., autoimmune enteritis and systemic lupus erythematosus).
- prior autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study drug.
- Presence of severe or uncontrolled cardiovascular disease.
- Medical history of active bleeding within 2 months prior to study entry, or currently achieved anticoagulant therapy, or susceptible to bleed by the judgement of investigator.
- Presence of concomitant diseases that are seriously endanger the safety of patient or affect the completion of the study by the investigator's judgment (e.g., uncontrolled hypertension, diabetes, thyroid diseases).
- Had received GCSF or blood transfusion treatment within 14 days prior to study entry.
- Female subjects of childbearing potential have a positive pregnancy test at the baseline.
- Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical or breast carcinoma in situ, local basal cell or squamous cell carcinoma of the skin, thyroid tumor.
- Adverse events occurred during previous anticancer therapy have not been recovered to ≤1 (CTCAE 5.0) except toxicity with no significant risk determined by investigator such as alopecia.
- Live vaccine was administered within 30 days prior to the first dose of the investigational drug, or was scheduled to be administered during the study period.
- Judgment by the investigator that the volunteer should not participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Open, Multicenter, Phase II Study to Investigate the Efficacy and Safety of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T/NK cell lymphoma.
- Conditions
- PTCL
- Being tested
- YY-20394 treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-20394 treatmentDrug
Each treatment cycle is comprised of 28-day consecutive dosing of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if they are benefit from the treatment and the toxicity is tolerable.
| Study group | Role | What they receive |
|---|---|---|
| YY-20394 treatment | Experimental | YY-20394 tablets, 20mg spec, 80mg QD, 28 days for each cycle. Receives: Drug: YY-20394 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: up to 12 months
Secondary outcomes (5)
DOR
Duration of response
Measured: up to 12 months
PFS
Progression free survival
Measured: up to 12 months
DCR
Disease control rate
Measured: up to 12 months
TTR
Time to response
Measured: up to 12 months
Safety and Tolerability
safety and tolerability of investigational Product assessed as the number of participants experiencing adverse events (AEs, CTCAE5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study startApr 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705090
- Sponsor's protocol ID
- YY-20394-010
- Status last verified
- Dec 2020
- First submitted
- 8 Jan 2021
- Last updated
- 12 Jan 2021
- 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 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Multicenter, Phase II Study to Investigate the Efficacy and Safety of YY-20394 in Patients With Relapsed or Refractory Peripheral T/NK Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04705090
- Acronym / sponsor ID
- YY-20394-010
- Conditions
- PTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 12 Jan 2021 (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.
A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T/NK cell lymphoma.
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 treatment | Experimental | Drug: YY-20394 treatmentYY-20394 tablets, 20mg spec, 80mg QD, 28 days for each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and/or females over age 18.
- Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T/NK cell lymphoma.
- Eastern Cooperative Oncology Group performance status of 0 to 1.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to Lugano 2014.
Key exclusion criteria (19 listed)
- Previous treatment with any PI3K-delta inhibitors.
- Uncontrolled pleural effusion and ascites.
- The dosage of steroid hormone (prednisone equivalent) was greater than 20mg/day, and lasted for more than 14 days.
- Medical conditions in swallowing difficulty, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/ or absorption of the investigational agent.
- Drugs that may prolong the QT (such as anti-arrhythmic drugs) could not be interrupted during the study period.
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-20394 treatmentEach treatment cycle is comprised of 28-day consecutive dosing of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if they are benefit from the treatment and the toxicity is tolerable. | Drug | YY-20394 treatment |
Primary outcome
ORR
Time frame: up to 12 months
Objective Response Rate
5 secondary outcomes
DOR
Time frame: up to 12 months
PFS
Time frame: up to 12 months
DCR
Time frame: up to 12 months
TTR
Time frame: up to 12 months
Safety and Tolerability
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YY-20394 treatment in people with PTCL, run by Shanghai YingLi Pharmaceutical Co. Ltd..
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 10 inclusion and 19 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 12 Jan 2021. 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 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 Hanying Bao, MD,PhD (86 21-51370693, hybao@yl-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 12 months). 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 Jan 2021.