Peripheral T cell lymphoma
Conditions
Interventions
Experimental group:Subjects took HZ-H08905 tablets 200mg (4 tablets) once a day, fasting 2 hours before and 1 hour after administration
And take chidamide simulant tablets 2 times a week, 30 mg (6 tablets) each time, the interval between the two doses should not be less than 3 days (such as Monday and Thursday, Tuesday and Friday, Wed
Control group:Subjects took chidamide tablets 30 mg (6 tablets) each time, twice a week, and the interval between the two doses should not be less than 3 days (such as Monday and Thursday, Tuesday and
And take HZ-H08905 analog tablets 1 time a day, 200mg (4 tablets) each time, fasting 2 hours before administration and 1 hour after administration. Continuous administration (28 days per cycle) until
Sponsors
Beijing Cancer Hospital/The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Males or females aged >=18 years (inclusive) 2.Histologically confirmed diagnosis of relapsed and/or refractory peripheral T-cell lymphoma(PTCL), and classified as one of the following subtypes by the 2022 edition of the World Health Organization [WHO] Classification of Tumors of Hematopoietic and Lymphoid Tissues: peripheral T-cell lymphoma, unspecified(PTCL-NOS), Nodal T follicular helper cell lymphomas(nTFHL)(angioimmunoblastic-type[nTFHL-AI], follicular-type[nTFHL-F], NOS[nTFHL-NOS]), ALK-positive or negative anaplastic large cell lymphoma(ALCL) and other peripheral T-cell subtypes identified by the investigators as suitable for participation in this study. NOTE:If it is calassified by the 2017 edition of the World Health Organization [WHO] Classification of Tumors of Hematopoietic and Lymphoid Tissues, the subtypes should be as listed below:peripheral T-cell lymphoma, unspecified(PTCL-NOS), angioimmunoblastic T-cell lymphoma(AITL), follicular T-cell lymphoma(FTCL), nodal peripheral T-cell lymphoma with T-follicular helper(TFH) phenotype(nPTCL-TFH), ALK-positive or negative anaplastic large cell lymphoma(ALCL) and other peripheral T-cell subtypesin the opinion of the investigator. 3.Patients must have received at least 1 prior line of systemic regimens(including anthracycline drugs, and brentuximab vedotin was required for patients with CD30 positive ALCL) , and confirmed as relapsed/refractory patients. Relapse was defined as relapse after complete response(CR) or progression after partial response(PR); Refractory was defined as progression disease(PD) after 2 cycles of treatment or stable disease(SD) after 4 cycles of treatment. 4.Patients must provide a written pathological or histological diagnosis report during the screening period and must agree to provide tumor tissue or tumor or lymph node tissue specimens for central laboratory testing. 5.Eastern Cooperative Oncology Group (ECOG) performance status must be ==3 months. 7.Patients must have at least 1 measurable disease(according to the lugano classification 2014), the definition of measurable lesions is: lymph node lesions length > 1.5 cm or any extranodal lesions length >1.0 cm with FDG-PET positive lesions. 8.Patients must have adequate organ function(no blood transfusion, no G-CSF, no medication correction within 14 days prior to screening) as outlined below: a)Bone marrow function:absolute neutrophil count (ANC) >= 1.0×109/L ( >=0.75×109/L for patients with bone marrow involvement); platelet count (PLT) >=75×109/L ( >=50×109/L for patients with bone marrow infiltration); hemoglobin (Hb) >=80g/L ( >=70g/L for patients with bone marrow involvement); b)Liver function: serum total bilirubin (TBIL) ==60 mL/min (Cockcroft-Gault formula); e)Cardiac function:Left ventricular ejection fraction (LVEF) >=50%; the Fridericia method corrects the QT interval (QTcF) to =< 450 ms for males and =< 470 ms for females [QTcF=QT/(RR*0.33), and RR is the standardized heart rate (RR =60/ heart rate)]. 9.Any non-hematological toxicities related to previous tre
Exclusion criteria
Exclusion criteria: 1.Tumor-like lesions with T-cell predominance; Mature T-cell and NK-cell leukaemias; Primary cutaneous T-cell lymphomas; Intestinal T-cell and NK-cell Lymphoid proliferations and lymphomas; Hepatosplenic T-cell lymphoma; EBV-positive NK/T-cell lymphomas or lymphoma leukemia(bone marrow examination lymphoma cell proportion >= 20%) or patients with central nervous system (CNS) involvement or concurrent hemophagocytic syndrome (specific subtypes can be found in Appendix 11) 2. Had other malignancies within 2 years (except clinical cured cervical carcinoma in situ, basal cell carcinoma, squamous cell carcinoma, or other carcinoma in situ). 3.Received other drugs or treatments before the first dose of the study drug: 1)Received anti-tumor treatment with Chinese herbs [with anti-tumor indications] within 4 weeks (such as Xihuang Wan, Fu Fang Ban Mao Jiao Nang, Xiao Ai Ping Pian, Kangai injection, Aidi injection, etc.); 2)Received anti-tumor treatments such as chemotherapy, radiotherapy, endocrine therapy, and major surgery within 4 weeks; 3)Received immunotherapy or targeted therapy within 4 weeks or 5 half-lives (whichever shorter) (e.g., bortezomib washed out for at least 22 days; lenalidomide washed out for at least 24 hours berfore the first dose); 4)high dose corticosteroids (equivalent to prednisone >= 20 mg/d) used for more than 14 consecutive days within 4 weeks. Other routes of local application (such as nasal spray, inhalation) or temporary use (for the treatment of asthma and chronic obstructive pulmonary disease) of corticosteroids are allowed; 5)Recived monoclonal antibody conjugated drug (ADC) therapy within 10 weeks; 6)Received autologous stem cell transplantation within 3 months; 7)Received chimeric antigen receptor T-cell immunotherapy(CAR-T) or chimeric antigen receptor NK-cell immunotherapy(CAR-NK) within 100 days; 8)Received allogeneic stem cell transplantation within 12 months. 4.Participated in other intervention clinical trials (such as drugs, vaccines, devices, etc.) within 4 weeks before the first dose (whichever longer), ADC drugs within 5 weeks, and CAR-T or CAR-NK cell therapy within 100 days. 5. Received any live or live attenuated vaccines within 4 weeks prior to the first dose or require receiving such vaccines at any time during the treatment period. 6.Previouly received treatment with histone deacetylase inhibitors (such as chidamide) (patients who have been continuously on medication for less than 2 weeks may be enrolled after evaluation by investigators). 7..Previouly received PI3K inhibitors(it may be considered for enrollment after evaluation by investigators for short-term andinformal users). 8.Patients with any clinical evidence of severe or uncontrolled systemic diseases, such as uncontrolled hypertension(systolic blood pressure >= 160mmHg or diastolic blood pressure >=100mmHg), uncontrollable hydrothorax and ascites, uncontrollable diabetes, and other serious mental, neurological, cardiovascular, respiratory, endocrine, digestive, liver and kidney diseases. 9.Have multiple factors (such as unable to swallow or have active gastrointestinal inflammation, intestinal obstruction, etc.) affecting drug intake and absorption in the opinion of the investigator. 10.Have uncontrolled active infections (viruses, bacteria, fungi, etc., such as infectious pneumonia) or required non-gastrointestinal anti-infective treatment. 11.Have active hepatitis B or C infection (hepatitis B: acute hepatitis B, untreated chro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Patient-reported quality of life evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival(Investigator evaluate);Overall response rate;Complete response rate;Duration of response;Disease response rate;Time to response; | — |
Countries
China
Contacts
Public ContactYunqin Song/Jie Jin
Beijing Cancer Hospital/The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed