Chronic lymphocytic leukemia/small cell lymphoma
Conditions
Interventions
treatment group:OBR/OR regimen
Sponsors
Shanxi Provincial People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: . Age =18 years old, gender unlimited; 2. Chronic lymphocytic/small cell leukemia was diagnosed by the iWCL 2018 criteria; 3. =1 previous treatment (duration of remission =3 years for patients receiving immunochemotherapy) 4. iwCLL2018 standard meets the treatment proof 5. ECOG score =2 points; 6. If the major organs are functioning normally, the following criteria are met: The standard of blood routine examination shall meet: ANC =1.0×10^9/L, PLT =30×10^9/L; Biochemical examination shall meet the following standards: TBIL < 2.0×ULN, CLL/SLL involved liver or diagnosed Gilbert syndrome (normal direct bilirubin), total bile red = 3 ULN; ALT and AST < 2.5×ULN (for CLL/SLL involved liver, ALT and AST < 5×ULN) 7. Endogenous creatinine clearance =30ml/min (Cockcroft-Gault formula). 8. Women of childbearing age must have already used reliable contraception or had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug 9. The patients participated in the study voluntarily and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients whose response has desease progressed with other BTK inhibitors in the past 2. Richter's syndrome is or has been confirmed by biopsy pathology 3. Patients have active and uncontrolled autoimmune hemocytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura 4. Other malignant tumors at present or in the past, except cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer cancer 5. Within 14 days prior to the first administration, corticosteroid therapy (with a dose equal to or higher than 20 mg/day prednisone or equivalent) was received, excluding inhalation medication, local medication, intra-articular medication, and prophylactic medication before or after the use of iodine contrast agents After discussion with the team leader, higher doses and longer durations of steroids may be allowed for treatment in the following situations: a) Treatment for autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL disease b) Short term (within 14 days) use of non active infections to treat diseases unrelated to CLL/SLL (such as arthritis, asthma) leading to acute exacerbation, including steroid dosage adjustments required for adrenal insufficiency 6. Patients who have undergone major surgical operations (tests for diagnostic purposes) or participated in clinical trials of drugs/devices within 4 weeks 7. There are uncontrollable or significant cardiovascular diseases, including: a) Within 6 months prior to the first administration of the investigational drug, there was a New York Heart Association (NYHA) grade II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia requiring treatment during screening, with a left ventricular ejection fraction (LVEF)470ms and males>450ms d) Subjects with symptoms or requiring medication for coronary heart disease e) Suffering from uncontrollable hypertension (on the basis of improving lifestyle, using a reasonable and tolerable sufficient amount of 2 or more antihypertensive drugs (including diuretics) for more than 1 month without meeting blood pressure standards, or taking 4 or more antihypertensive drugs to effectively control blood pressure) 8. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 s or APTT > 1.5 ULN) or had active bleeding within 2 months prior to screening, or was taking anticoagulant drugs, or had what the investigator considered a definite tendency to bleed 9. Arterial/venous thrombotic events that occurred within the 12 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism 10. Clinically obvious gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) 11. Active or uncontrolled HBV (HBsAg positive and HBV DNA titer positive), HCV Ab positive or HIV positive 12. Uncontrolled, active systemic fungal, bacterial, viral or other infection (defined as showing persistent signs/sym
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response;Undected minimal residual disease;duration of response;Progression-free survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactHe Jianxia
Shanxi Provincial People‘s Hospital
Outcome results
None listed