Small Lymphocytic LymphomaPhase 1NCT04279405
A Phase Ib Study of YY-20394 in Participants With B-cell Hematologic Malignancies
A Phase 1 study testing YY-20394 in people with Small Lymphocytic Lymphoma and Lymphoplasmacytic Lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor. eligible participants will initiate oral therapy with YY-20394 at a starting dose of 80mg taken once per day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone 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
- 43 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 1 Jun 2023
- 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
- histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma)
- prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least
- eastern cooperative oncology group performance status of 0 to 2
- life expectancy of at least 3 months
- presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions
- acceptable organ functions
Show all 9Show fewer
- discontinuation of all other antitumor therapies before the first drug dose administration
- for men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up six periods
- willingness and ability to provide written informed consent and to comply with the protocol requirements
Who cannot join
- prior therapy with PI3K-delta inhibitors（except the intolerable subjects）
- the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days
- medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product
- concurrent drugs which maybe prolong the QT during the study period
- subjects with central nervous system metastasis
- Prior or current medical condition of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc
Show all 16Show fewer
- active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- known history of chronic active hepatitis B infection, chronic active hepatitis C
- known history of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation
- autologous hematopoietic stem cell transplantation was received within 90 days before the first dose administration
- prior or ongoing heart disease, including: angina pectoris, clinically significant arrhythmia, myocardial infarction, heart failure, and any other heart disease judged by the researchers not eligible to the study
- pregnancy or breastfeeding
- prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant or impair the assessment of study results
- receiving granulocyte colony-stimulating factor(GCSF) or blood transfusion within seven days before screening
- history of a non-lymphoma malignancy except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ
- subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason.
Trial locations and contacts
1 site in 1 country.
China1 site
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin
About this study
Official title: A Phase 1b Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Recurrent and/or Refractory B-cell Hematologic Malignancies
Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor. eligible participants will initiate oral therapy with YY-20394 at a starting dose of 80mg taken once per day. treatment with YY-20394 can continue in compliant participants as long as the study is still ongoing and the participants appear to benefiting from treatment with acceptable safety.
- Conditions
- Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- YY-20394
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-20394Drug
YY-20394 80mg tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| YY-20394 | Experimental | treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity. Receives: Drug: YY-20394 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events evaluated by NCI CTCAE V5.0
incidence of adverse events and associated dose of YY-20394
Measured: Throughout the study for approximately 2 years
Overall response rate
the percentage of participants achieving a complete response or partial response
Measured: Throughout the study for approximately 2 years
disease control rate
the percentage of participants achieving a complete response or partial response or stable disease
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 posted21 Feb 2020
- Study start15 Jun 2020
- Primary completion30 Sep 2021
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Lymphocytic 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
- 43 participants (actual)
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
- NCT04279405
- Sponsor's protocol ID
- YY-20394-007
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2020
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Assess the Safety and Efficacy of YY-20394 in Subjects With Recurrent and/or Refractory B-cell Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT04279405
- Acronym / sponsor ID
- YY-20394-007
- Conditions
- Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 21 Feb 2020 (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.
Protocol YY-20394-007 is a phase1 open-label, single-arm, multi-centre study to assess the safety and efficacy of YY-20394 in participants with relapse and/or refractory B cell malignant hematological tumor. eligible participants will initiate oral therapy with YY-20394 at a starting dose of 80mg taken once per day. treatment with YY-20394 can continue in compliant participants as long as the study is still ongoing and the participants appear to benefiting from treatment with acceptable safety.
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-20394treatment with YY-20394 will be continued until tumor progression or development of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically or cytologically confirmed relapse and/or refractory B cell hematologic malignancies(Excluding follicular lymphoma)
- prior treatment with ≥1 prior standard anti-tumor regimens and 2 courses of treatments at least
- eastern cooperative oncology group performance status of 0 to 2
- life expectancy of at least 3 months
- presence of >1.5cm radiographically measurable lymphadenopathy or extranodal lymphoid malignancy, and legibility in two vertical directions
Key exclusion criteria (16 listed)
- prior therapy with PI3K-delta inhibitors（except the intolerable subjects）
- the dosage of steroid hormone(predisone equivalent) was greater than 20mg/d, and lasted for more than 14 days
- medical condition of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditional that may hamper compliance and/or absorption of the investigational product
- concurrent drugs which maybe prolong the QT during the study period
- subjects with central nervous system metastasis
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-20394YY-20394 80mg tablet administered orally once daily | Drug | YY-20394 |
Primary outcome
Adverse events evaluated by NCI CTCAE V5.0
Time frame: Throughout the study for approximately 2 years
incidence of adverse events and associated dose of YY-20394
Overall response rate
Time frame: Throughout the study for approximately 2 years
the percentage of participants achieving a complete response or partial response
disease control rate
Time frame: Throughout the study for approximately 2 years
the percentage of participants achieving a complete response or partial response or stable disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
Related trials for Small Lymphocytic Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Small Lymphocytic Lymphoma and Lymphoplasmacytic 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 13 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events evaluated by NCI CTCAE V5.0 (time frame: Throughout the study for approximately 2 years). 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 13 Jun 2024.