A phase II study of linperlisib (YY-20394) in patients with relapsed or refractory peripheral T/NK cell or Cutaneous T Cell lymphoma
- Conditions
- Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell LymphomaTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501431-16-00
- Lead Sponsor
- Shanghai Yingli Pharmaceutical Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 107
Adult patient =18 years of age at the time of signing the informed consent., Has measurable disease of CTCL defined by at least one of the following, within 28 days prior to start of study treatment: Revised International Working Group (Oslen, 2011) Classification for systemic lymphoma or Atypical and/or malignant lymphocytes quantifiable by flow cytometry or morphology in blood mSWAT (Modified Severity Weighted Assessment Tool) >0, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1., Has adequate organ function as defined below: System Laboratory Value Haematological Absolute neutrophil count =1.0×109/L Note: No growth factor supports within 14 days of first dose Platelet count =75×109/L Note: =50 × 109/L for patients with bone marrow infiltration No blood product transfusion is allowed within 14 days of first dose Haemoglobin =8.0 g/L Note: criteria must be met without erythropoietin dependency and no blood product transfusion is allowed within 14 days of first dose Hepatic Total bilirubin =1.5×ULN Note: Patients with Gilbert’s Syndrome or other benign congenital hyperbilirubinemia may be eligible at the Investigator’s discretion in consultation with the Medical Monitor, if = 3 × ULN Alanine aminotransferase =2.5×ULN Note: = 5 × ULN if there is liver involvement by lymphoma Aspartate aminotransferase =2.5×ULN Note: = 5 × ULN if there is liver involvement by lymphoma Renal CrCl calculated by Cockcroft-Gault formula CrCl =50 mL/min Coagulation INR < 1.5 without anti-coagulation therapy Activated partial thromboplastin time aPTT =1.5 ULN Cardiac Left ventricular ejection fraction LVEF = 50% by an echocardiogram (ECHO) or multigated acquisition scan (MUGA). QTcF <470 ms Abbreviations: CrCl=creatinine clearance; RBC=red blood cell; QTcF=QT interval corrected using Fridericia’s formula; ULN=upper limit of normal., CTCL patients who are on low or intermediate potency topical corticosteroids or low dose (= 10mg prednisone or equivalent) systemic steroids may participate and continue the steroids use, if they are on a stable dose for at least 4 weeks before the start of study treatment. Local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications., 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 patients 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 the time of informed consent, 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., Must be willing and able to adhere to the study and lifestyle restrictions as judg
Patients with peripheral T-cell lymphoma having known central nervous system (CNS) invasion (either CNS lymphoma or leptomeningeal lymphoma)., Medical history of other primary malignant tumors in the past 3 years, or any evidence of residual disease from a previously diagnosed malignancy. Note: Exceptions are 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, localized prostate cancer previously fully resected undergoing surveillance or other adequately treated Stage 1 cancer currently in complete remission., Has received prior treatment with linperlisib (YY-20394), or other PIK3-d inhibitors. Patients who have received prior treatment with other PIK3-d inhibitors or PIK3-d, -? dual inhibitors, but were intolerant to them, maybe included, only at investigators’ discretion and approved by the Sponsor., 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 cytotoxic anticancer therapy, or definitive radiotherapy within 28 days (14 days for palliative radiation) prior to the first dose of study treatment., Has received prior targeted small molecule therapy, or systemic retinoids, interferons, vorinostat, romidepsin and denileukin diftitox within 14 days or 5 half-lives whichever is longer prior to the first dose of study treatment., Has received topical retinoids, nitrogen mustard, imiquimod within 1 week prior to the first dose of study treatment., 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 surgery prior to starting study treatment., Has had autologous stem cell transplant within 3 months prior to first dose of study treatment., Has allogeneic transplant or solid organ transplant within 6 months prior to the first dose of study drug. CTCL patients with history of allogeneic transplant will be excluded., 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, any other cardiac disorder not suitable for participation in this study based on the judgment of the investigator. Note: During the treatment period, patients should not take medication that may prolong the QT (such as antiarrhythmic drugs)., Has graft versus host disease (GvHD) or who still require immunosuppression., Use of medications or foods that are strong cytochrome CYP3A inhibitors, strong CYP3A inducers within 14 days prior to first dose of study treatment or 5 half-lives of the given drug, whichever is longer., Use of any drug that may result in QT prolongation (e.g., antiarrhythmic agents) cannot be interrupted during the study., Has medical conditions requiring the use of immunosuppressive medications (in dosing exceeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method