Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Zhejiang DTRM Biopharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age≥18 years, gender is not limited. Patients are voluntary to sign the informed consent form.
B-Cell Lymphoma based on WHO classified definition: including chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL); chronic lymphocytic leukemia with 17p-; mantle cell lymphoma (MCL); Waldenstrom's macroglobulinemia(WM); Diffuse large B-cell lymphoma (DLBL or DLBCL) etc.
Measurable lesion: non-Hodgkin 's lymphoma requires at least a two-dimensional lesion diameter ≥ 2 cm, chronic lymphocytic leukemia ≥ 5000 leukemia cells / mm3, Waldenstrom's macroglobulinemia IgM ≥ 1000 mg / dL, bone marrow lymph plasma -like cells infiltration, Histopathologically diagnosed as Diffuse Large B- Cell Lymphoma.
Investigator judges that the treatment is needed.
Patients, who at least failed in lymphoma treatment once and without standard therapeutic options, can't satisfy the requirement or decline treatment or failed in autologous stem cell transplantation for Diffuse Large B- Cell Lymphoma.
ECOG (Eastern Cooperative Oncology Group) performance status 0 \~1
Life expectancy greater than 4 months
Ability to swallow capsules
Hematologic functions satisfy: Neutrophils ≥1.5×109 / L ( according to the investigators' opinion , if they judge that the patients' neutrophil count lower than this threshold, which caused by chronic lymphocytic leukemia and bone marrow infiltration, those patients are eligible to be included. ), platelet(PLT) ≥75×109/L, HB≥80g/L
Renal functions satisfy: Creatinine (Cr) ≤ 1.5 times of upper limit of normal persons; creatinine clearance rate≥50ml/min (estimated by Cockcroft-Gault formula or detected by nuclear medicine scan or 24 hours urine method)
Liver functions satisfy: AST and ALT≤2.5 times of normal value, bilirubin ≤1.5 times of normal value
Coagulation function: international normalized ratio (INR) and APTT ≤ 1.5 times of normal value;
Throughout the course of the study and 90 days of treatment interruption, female of childbearing age and fertile males who must take one of the following effective contraception measures: abstinence, barrier-type dual contraceptive methods, IUDs, administration of hormonal contraception drug.
Male subjects are prohibited sperm donation from the start to the end of treatment within 90 days.
You may not be if
Patients with brain metastasis
Disease with changes of pathological tissue types (including large cell transformation)
Patients who received allogeneic stem cell transplantation within 6 months, or with organized incompatibility reaction (GVHD), requires immunosuppressive therapy
Patients who received steroid anti-tumor therapy within 7 days, or receive chemotherapy within 2 weeks, or receive monoclonal antibody therapy within 4 weeks, prior to first administration of DTRMWXHS-12 capsule.
Patients received other BTK inhibitor therapy
Patients had early received chemotherapy but their toxicity has not been cleared (according to NCI-CTCAE 4.03, unrecovered toxicity grade ≤1)
Patients who received Chinese herbal anti-tumor therapy within 1 week before the start of study
Patient with a history of other malignant within 2 years before enrollment, except (1) adequately treated in situ cervical cancer;(2) Local basal cell carcinoma or squamous cell carcinoma (3) Local malignant tumor which has been completely treated (by surgery or other means)
Patients with uncontrolled systemic infection requiring intravenous anti-infection treatment
Patients received major surgery in the past 4 weeks
Patients with HIV infection, HBs-Ag positive
According to New York Heart Association (NYHA) classification, patients with cardiovascular disease of grade ≥3
Patients with history of Myocardial infarction, acute coronary syndrome (unstable angina), receiving coronary angioplasty and stent implantation within 6 months of study entry
Patients applied something which may cause QT prolongation or accompany by torsades healer within 7 days prior to enrollment.
Prolonged QTc interval (defined as a QTc\> 450 ms) or other significant ECG abnormalities, including second degree atrioventricular block type Ⅱ, third degree atrioventricular block, or bradycardia (heart rate less than 50 beats / min),ECG QTc\> 450 milliseconds, the ECG may be submitted to expert for centralized evaluation
Subjects, the investigators think whose existing renal disease, neurological / psychiatric disorders, liver or endocrine disorders could affect their participating in the experiment
Subjects with poor compliance
Subjects are using CYP3A inhibitors (or inducer)
Clareo Health | Safety, Tolerability and PK of BTK Inhibitor DTRMWXHS-12 in Patients With B-Cell Lymphomas
