Relapsed or refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma
Conditions
Interventions
PTCL Single drug group:Intravenous drip of BEBT-908
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The subject is willing to sign the informed consent form (ICF) after a comprehensive understanding; 2.Aged >= 18 years, male or female; 3.Histological diagnosis (need to be confirmed by central pathology): peripheral T-cell lymphoma (PTCL): non-specified PTCL, NK/T-cell lymphoma (nasal type), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), subcutaneous panniculitis-like T-cell lymphoma, enteropathic T-cell lymphoma (EATL) and hepatosplenic T-cell lymphoma (HSTL),etc; 4.Prior therapy:Relapsed/refractory PTCL that has failed or is intolerable after at least one systemic systemic treatment and/or has no effective standard treatment (NK/T cell lymphoma needs to include pegaspartase in the previous treatment). The definition of relapse/refractory is as follows: Relapse: refers to the disease progression after the subject has received adequate first-line treatment in the past, including: (1) Completion of treatment in accordance with clinically recommended standards or routine protocols (first-line chemotherapy combined with radiotherapy for early patients) The recommended chemotherapy regimen is at least 2 phases; first-line systemic treatment is the main treatment for advanced patients, patients who have received hematopoietic stem cell transplantation for at least 4 cycles, and patients who have not received transplantation for at least 6 cycles); (2) response for 1-3 years, unsuitable or not Receive autologous hematopoietic stem cell transplantation rescue treatment. Refractory: Refers to the subject who has not received adequate first-line treatment before, or the disease progresses during the treatment/full treatment within 1 year, including: (1) Treatment in accordance with clinically recommended standards or conventional programs, and the treatment period >= 2 cycles did not reach the disease Stable (SD),or partial response (PR) is not achieved for 4 cycles or more of the course of treatment;(2)If the best curative effect or the cause of the end is disease progression (PD), the number of treatment courses is not required;(3)Accepted clinically recommended standards Or the disease progresses again after the conventional regimen treatment is >= 2 lines;(4)Patients who relapse after autologous hematopoietic stem cell transplantation; 5.Life expectancy > 3 months; 6.ECOG score 0-2 points; 7.Presence of at least one measurable and evaluable tumor lesion (Lugano2014 criteria); 8.Organ function level must meet the following requirements: peripheral blood:absolute neutrophil count (ANC) >= 1.0 x 10^9/L; hemoglobin (HGB) >= 80g/L; platelet count (PLT) >= 75 x 10^9/L;liver and kidney function:serum total bilirubin <= 1.5 x ULN;serum creatinine < 1.5 x ULN; ALT and AST <= 2.5 x ULN, or liver infiltration leading to impaired liver function and ALT and AST <= 5 x ULN as judged by the investigator.
Exclusion criteria
Exclusion criteria: 1.Received any other anti-tumor therapy (including cytotoxic chemotherapy, molecular targeted therapy, immunotherapy or other biological therapy within 4 weeks before the first use of the research drug, mitomycin or nitrosamine within 6 weeks,small molecule targeted drugs at least 2 weeks or at least 5 half-lives between the last administration (whichever is the longer), and traditional Chinese medicine with antineoplastic indications at least 2 weeks from the last administration; 2.Patients received blood transfusion,recombinant human thrombopoietin, erythropoietin, granulocyte colony-stimulating factor and other treatments within 2 weeks before the first use of the study drug; 3.Autologous hematopoietic stem cell transplantation within 3 months before enrollment; 4.Patients who have received the following treatments within 7 days prior to study entry: drugs known to be potent inhibitors/inducers of CYP 3A4, drugs known to significantly prolong the QT interval; 5.Major surgery requiring general anesthesia within 4 weeks before enrollment; Surgery requiring local anesthesia/epidural anesthesia and the patient has not yet recovered within 2 weeks prior to enrollment (except bone marrow biopsy or local lymphoid tissue biopsy); 6.Patients with uncontrolled active infection; 7.Prednisone > 10mg per day (or equivalent) within 7 days prior to enrollment, with the following exceptions: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids, and short-term use of corticosteroids for prophylaxis, such as contrast media; 8.At rest, the mean corrected QT interval (QTc) > 450 msec (male) or > 470 msec (female) in 3 times of electrocardiogram (ECG) examination (it is only necessary to retest and take the mean corrected value of 3 times when the QTc > 450 msec (male) or > 470 msec (female) in the first ECG examination); history of long QT syndrome or confirmed family history of long QT syndrome; history of clinically significant arrhythmia, or current use of antiarrhythmic drugs or implanted defibrillation device for treatment of ventricular arrhythmia; 9.Uncontrolled electrolyte imbalance that may affect the effect of QTc prolonging drugs (e.g., hypocalcemia = 160/95mmHg; 12.Patients with persistent >= grade 2 toxicity (CTCAE 5.0 criteria) after previous treatment (chemotherapy or biological therapy), which is not stable at enrollment (except for hair loss); 13.Concomitant disease:any other malignant tumor (except for adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ); central nervous system lymphoma; diabetes with poor glycemic control (random blood glucose >= 11.1mmol/L,or HbA1c >= 8.5% after hypoglycemic therapy); severe lung disease (CTCAE 5.0 grade III-IV); severe heart disease (including any of the following:LVEF < 50% by cardiac radionuclide scan (MUGA) or echocardiography (ECHO); unstable angina pectoris; symptomatic pericarditis; myocardial infarction in the past 6 months, persistent myocardial enzyme elevation or abnormal regional wall during LVEF function test; history of congestive heart failure (New York Heart Association functional classification III-IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;TTR;TTP;PFS;OS; | — |
Countries
China
Contacts
Public ContactQian Changgeng
Outcome results
None listed