Phase
Condition
Hematologic Cancer
Lymphoproliferative Disorders
Lymphoma
Treatment
LP-168 tablet
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Per 2017 revised WHO lymphoma classification criteria, subject must have either:
Diagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC.
Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\ SLL \ MCL \ MZL \ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC.
Adequate hematologic function.
Adequate hepatic and renal function.
Ability to receive study drug therapy orally and willing to receive examinations.
Willingness of men and women of reproductive potential (defined as followingmenarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] orsurgically sterile) to observe conventional and effective birth control.
Exclusion
Key Exclusion Criteria:
According to the 2017 revised WHO Lymphoma Classification Criteria, patientsdiagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma,lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferativedisease(PTLD).
Prior malignancy (other than the disease under study) within the past 3 years,except for curatively treated basal or squamous cell skin cancer, carcinoma in situof the cervix or breast cancer.
Subjects who have received the following treatments within 4 weeks or 5 half-livesbefore the first dose of LP-168:
Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
- Subjects who have received the following treatments within 2 weeks before the firstdose of LP-168:
Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
Disease states where clinical manifestations may be difficult to control, includingHIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Diseaseaffects the central nervous system with obvious symptoms; Autoimmune hemolyticanemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions thatmay severely affect the study drug absorption or pharmacokinetic parameters.
Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, andbone marrow aspiration.
Study Design
Study Description
Connect with a study center
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, Beijing 100089
ChinaActive - Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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