PTCL
Conditions
Brief 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.
Interventions
DRUGYY-20394 treatment
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.
Sponsors
Shanghai YingLi Pharmaceutical Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 12 months | Objective Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR | up to 12 months | Duration of response |
| PFS | up to 12 months | Progression free survival |
| DCR | up to 12 months | Disease control rate |
| TTR | up to 12 months | Time to response |
| Safety and Tolerability | 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. |
Contacts
Primary ContactHanying Bao, MD,PhD
Backup ContactYang Shu, MMeD
Outcome results
None listed