Follicular LymphomaPhase 2NCT04379167
A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Follicular Lymphoma
A Phase 2 study testing YY-20394 in people with Follicular Lymphoma, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
A Phase 2, single arm, open label clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of YY-20394 as monotherapy in patients with relapsed/refractory follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- YY-20394
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2020to 30 Dec 2022
- 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
- Age
- Patient is ≥18 years of age at the time of signing the informed consent. Type of Patient and Disease Characteristics
- Has histologically confirmed follicular non-Hodgkin's lymphoma Grade ≤3 according to the WHO 2017 classification system.
- Has radiographically measurable disease as per Lugano Criteria with at least one nodal lesion (which has not been previous radiated) that is >15 mm in long axis, regardless of the length of the short axis, AND/OR extranodal lesion of >10 mm in long and short axis.
- Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma. Refractory disease is defined as persistence of evaluable disease after therapy with documented disease progression at the time of enrollment.
- Must have relapsed (experienced disease progression) during their last follicular lymphoma regimen after receiving at least two cycles of therapy or within 12 months after completing their last regimen for follicular lymphoma.
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- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has a life expectancy >3 months.
- Has adequate organ function as defined in Table 5 1. Specimen for this assessment must be collected within 14 days prior to the first dose of study treatment:
- Patient is male or female.
- 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.
- Female patient 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 28 days before the start of study treatment, 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.
- Patient is capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Must be willing and able to adhere to the study and lifestyle restrictions.
Who cannot join
- Has follicular lymphoma histological Grade >3 or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- Has presence of central nervous system (CNS) disease (either CNS lymphoma or leptomeningeal lymphoma) that is clinically uncontrolled or diagnosed within 4 months of enrollment.
- 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.
- Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
- Has peripheral neuropathy that is ≥Grade 2 with pain.
- Has a medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the study treatment.
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- Has diarrhea of CTCAE Grade >1.
- Has a history of or concurrent interstitial lung disease of any severity and/or severely impaired lung function.
- Prior history of drug-induced colitis or drug-induced pneumonitis.
- Has a systemic infection or other serious infection requiring systemic treatment within 14 days before the first dose of study treatment.
- Has a known additional malignancy that is progressing or required active treatment within 2 years of enrollment.
- Note: 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 are not excluded.
- Prior/Concomitant Therapy
- Has received prior treatment with YY-20394, or other PIK3-δ inhibitors.
- 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.
- Has received radioimmunoconjugates or toxin conjugates within 12 weeks before the first dose of study treatment.
- Has had received prior systemic anticancer therapy, or targeted small molecule therapy, or definitive radiotherapy ≤28 days (14 days for palliative radiation) prior to the first dose of study treatment.
- Note: Patients must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Patients with ≤Grade 2 alopecia may be eligible.
- Note: Patients must have recovered from all radiation-related toxicities.
- 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 the toxicity and/or complications from the treatment prior to starting study treatment.
- Has had autologous stem cell transplant within 6 months prior to first dose of study treatment, or prior allograft stem cell transplantation at any time.
- Use of medications or foods that are moderate cytochrome P (CYP)3A inhibitors, strong or moderate CYP3A inducers within 14 days prior to first dose of study treatment or 5 half-lives of the given drug, whichever is longer.
- Has a history of immunodeficiency or 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 Sponsor.
- Has received a live vaccination within 4 weeks before the first dose of study treatment. 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.
- Has received granulocyte colony-stimulating factor or blood transfusion within 7 days before start of screening.
- Prior/Concurrent Clinical Study Experience
- Is currently participating in or has participated in a study with an investigational compound or device within ≤4 weeks prior to the first dose of study treatment.
- Note: Patients who have entered the follow-up phase of an investigational study may participate so long as it has been at least 4 weeks since the last dose of the previous investigational agent.
- Diagnostic Assessments
- Has a known history of or newly diagnosed infection with HIV, Hepatitis B (defined as HBsAg reactive) or hepatitis C virus (HCV) (defined as detection of qualitative HCV virus RNA).
- 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.
- Other Exclusions
- Patient is pregnant or breastfeeding or expecting to conceive of father children for the duration of the study.
- Has a history of hypersensitivity to YY-20394 and/or any excipients.
- Has a history of hypersensitivity to radiological imaging contrasting agents.
- Has a known psychiatric disorder that would interfere with proper cooperation with the requirements of the study.
- Is a regular user of illicit or recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse of dependence.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 2, Single Arm, Open Label Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of YY-20394 in Patients With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma Who Have Failed at Least Two Prior Systemic Therapies.
A Phase 2, single arm, open label clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of YY-20394 as monotherapy in patients with relapsed/refractory follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies
- Conditions
- Follicular Lymphoma
- Being tested
- YY-20394
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-20394Drug
YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. PI3K-δ signaling pathways are frequently hyperactive in B-cell cancers, making inhibition of PI3K-δ a promising target for B-cell malignancies. YY 20394 has high potency against PI3K-δ, but with markedly improved selectivity in in vitro assays compared to idelalisib. This higher selectivity for PI3K-δ may decrease the risk of serious infection seen with idelalisib and duvelisib (a PI3K-γ/δ dual inhibitor) due to strong immune suppression.
| Study group | Role | What they receive |
|---|---|---|
| YY-20394 | Experimental | YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. Receives: Drug: YY-20394 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response (OR)
complete response (CR) or partial response (PR).
Measured: throughout the study approximately 2 years
Secondary outcomes (1)
evaluate 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 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 posted7 May 2020
- Study start30 Dec 2020 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 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
- NCT04379167
- Sponsor's protocol ID
- YY-20394-009
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan to make individual participant data (IPD) available to still remains uncertain.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single Arm, Open Label Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of YY-20394 in Patients With Relapsed/Refractory Follicular Non-Hodgkin's Lymphoma Who Have Failed at Least Two Prior Systemic Therapies.
- ClinicalTrials.gov ID
- NCT04379167
- Acronym / sponsor ID
- YY-20394-009
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 7 May 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.
A Phase 2, single arm, open label clinical study to evaluate the efficacy, safety, tolerability and pharmacokinetics of YY-20394 as monotherapy in patients with relapsed/refractory follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies
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 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age
- Patient is ≥18 years of age at the time of signing the informed consent. Type of Patient and Disease Characteristics
- Has histologically confirmed follicular non-Hodgkin's lymphoma Grade ≤3 according to the WHO 2017 classification system.
- Has radiographically measurable disease as per Lugano Criteria with at least one nodal lesion (which has not been previous radiated) that is >15 mm in long axis, regardless of the length of the short axis, AND/OR extranodal lesion of >10 mm in long and short axis.
- Has received at least two prior lines of systemic therapy (excluding radiation) for follicular lymphoma. Refractory disease is defined as persistence of evaluable disease after therapy with documented disease progression at the time of enrollment.
Key exclusion criteria (38 listed)
- Has follicular lymphoma histological Grade >3 or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- Has presence of central nervous system (CNS) disease (either CNS lymphoma or leptomeningeal lymphoma) that is clinically uncontrolled or diagnosed within 4 months of enrollment.
- 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.
- Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs).
- Has peripheral neuropathy that is ≥Grade 2 with pain.
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 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. PI3K-δ signaling pathways are frequently hyperactive in B-cell cancers, making inhibition of PI3K-δ a promising target for B-cell malignancies. YY 20394 has high potency against PI3K-δ, but with markedly improved selectivity in in vitro assays compared to idelalisib. This higher selectivity for PI3K-δ may decrease the risk of serious infection seen with idelalisib and duvelisib (a PI3K-γ/δ dual inhibitor) due to strong immune suppression. | Drug | YY-20394 |
Primary outcome
Overall response (OR)
Time frame: throughout the study approximately 2 years
complete response (CR) or partial response (PR).
1 secondary outcome
evaluate duration of response (DOR)
Time frame: throughout the study 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 7 May 2020.
- Individual participant dataSharing planned: Yes. The plan to make individual participant data (IPD) available to still remains uncertain.
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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 in people with Follicular Lymphoma, 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 17 inclusion and 38 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 7 May 2020. 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?
Overall response (OR) (time frame: throughout the study 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 7 May 2020.