Relapsed or Refractory Peripheral T-Cell LymphomaPhase 1NCT04108325
A Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
A Phase 1 study testing YY-20394 in people with Relapsed or Refractory Peripheral T-Cell Lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in China.
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 cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Peripheral T-Cell Lymphoma
- 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
- 58 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2020to Dec 2021
- Phase
- Phase 1
- 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 cell lymphoma.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to IRWG.
- Adequate organ function.
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- Had anti-tumor treatments greater than or equal to 2 weeks prior to the first dose of investigational product (including TKI, chemotherapy, radiotherapy, immunotherapy and major surgery).
- 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.
- Able to comply with the protocol judged by investigator.
- Provision of signed and dated, written informed consent prior to any study- specific evaluation.
Who cannot join
- 1. Previous treatment with any PI3K-delta ihinibitors. 2. Uncontrolled pleural effusion and ascites. 3. the dosage of steroid hormone ( prednisone equivalent ) was greater than 20mg/day, and lasted for more than 14 days. 4. Medical conditions in swallowing, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/or absorption of the investigational agent. 5. During the study period, drugs that may prolong the QT (such as anti arrhythmic drugs) could not be interrupted. 6. Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression. 7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy(such as pneumonia). 8. Active infection with hepatitis B and C virus ( Volunteers with HBsAg or HBcAb positive and HBV-DNA greater than or equal to 1000 coRpies/ml or 200IU/ml; HCV antibody and HCV-RNA positive ). 9. History of immune deficiency ( acquired or congenital ), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation. 10. Presence of severe or uncontrolled cardiovascular disease. 11. The baseline pregnancy test was positive in pregnant women, lactating women or fertile women. 12. According to the judgement of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.). 13. Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical in situ, local basal cell carcinoma of the skin.
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Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 3000
Lugui Qiu, MD,PhD, 022-23909083, qiulg@ihcams.ac.cn
About this study
Official title: A Single-Arm, Open-Label, Multi-Center, Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-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 cell lymphoma.
- Being tested
- YY-20394
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-20394Drug
Each treatment cycle is comprised of 28-day consecutive of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if there are benefit from the treatment and the toxicity is tolerable.
| Study group | Role | What they receive |
|---|---|---|
| YY-20394 | Experimental | YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. Receives: Drug: YY-20394 |
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
DCR
Disease control rate
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 posted30 Sep 2019
- Study start30 Mar 2020
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Peripheral T-Cell LymphomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT04108325
- Sponsor's protocol ID
- YY-20394-004
- Status last verified
- Jan 2021
- First submitted
- 26 Sep 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multi-Center, Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04108325
- Acronym / sponsor ID
- YY-20394-004
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Sep 2019 (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 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 | Experimental | Drug: YY-20394YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and/or females over age 18
- Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T cell lymphoma.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to IRWG.
Key exclusion criteria (2 listed)
- 1. Previous treatment with any PI3K-delta ihinibitors. 2. Uncontrolled pleural effusion and ascites. 3. the dosage of steroid hormone ( prednisone equivalent ) was greater than 20mg/day, and lasted for more than 14 days. 4. Medical conditions in swallowing, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/or absorption of the investigational agent. 5. During the study period, drugs that may prolong the QT (such as anti arrhythmic drugs) could not be interrupted. 6. Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression. 7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy(such as pneumonia). 8. Active infection with hepatitis B and C virus ( Volunteers with HBsAg or HBcAb positive and HBV-DNA greater than or equal to 1000 coRpies/ml or 200IU/ml; HCV antibody and HCV-RNA positive ). 9. History of immune deficiency ( acquired or congenital ), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation. 10. Presence of severe or uncontrolled cardiovascular disease. 11. The baseline pregnancy test was positive in pregnant women, lactating women or fertile women. 12. According to the judgement of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.). 13. Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical in situ, local basal cell carcinoma of the skin.
- -
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-20394Each treatment cycle is comprised of 28-day consecutive of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if there are benefit from the treatment and the toxicity is tolerable. | Drug | YY-20394 |
Primary outcome
ORR
Time frame: up to 12 months
Objective Response Rate
DCR
Time frame: up to 12 months
Disease control rate
Safety and Tolerability
Time frame: up to 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YY-20394 in people with Relapsed or Refractory Peripheral T-Cell Lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd. 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 11 inclusion and 2 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 28 Jan 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanying Bao, PhD (86 21-5137069, 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). The study lists 3 primary outcomes in all. 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 28 Jan 2021.