CTIS2023-504044-34-00招募中1 期
Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia - 54179060CLL2032
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •2. Diagnosis of CLL/SLL that meets iwCLL diagnostic criteria, 3. For I+V cohorts: ECOG performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2, 4. Active disease meeting at least 1 of the following iwCLL criteria for requiring treatment: a. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. b. Massive (ie, =6 cm below the left costal margin) or progressive or symptomatic splenomegaly. c. Massive nodes (ie, =10 cm in longest diameter) or progressive or symptomatic lymphadenopathy. d. Progressive lymphocytosis with an increase of =50% over a 2-month period, or LDT <6 months. e. Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids. f. Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine). g. Disease-related symptoms as defined by any of the following: i. Unintentional weight loss =10% within the previous 6 months. ii. Significant fatigue (ie, ECOG performance scale 2 or worse; cannot work or unable to perform usual activities). iii. Fevers =100.5°F or 38.0°C for =2 weeks without evidence of infection. iv. Night sweats for =1 month without evidence of infection., 15. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days (except for pegylated G-CSF [pegfilgrastim] and darbepoetin, which require at least 14 days) prior to screening laboratory assessment defined as: a. ANC >750/µL independent of growth factor support; b. Platelet count >50,000/µL independent of transfusion support for at least 7 days prior to enrollment; c. Hemoglobin >8.0 g/dL independent of transfusion support for >7 days prior to enrollment, 16. Adequate hepatic function, defined as: a. Serum AST or ALT =3.0×ULN; b. Bilirubin =1.5×ULN (unless bilirubin rise is due to congenital nonhemolytic hyperbilirubinemias or of non-hepatic origin); c. Prothrombin time/international normal ratio <1.5×ULN and activated partial thromboplastin time <1.5×ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder), 17. Adequate renal function, defined as follows (using the Cockcroft-Gault equation): a. For I+V cohorts: i. In participants aged <75 years at enrollment, CrCl =45 mL/min; ii. In participants aged =75 years at enrollment, CrCl =60 mL/min. b. For ibrutinib monotherapy cohorts, CrCl =45 mL/min
排除标准
- •1. Medical history of: a. Other malignancies, except: i. Any malignancy that was not progressing nor requiring treatment change in the last 12 months. ii. Malignancies treated within the last 12 months and considered at very low risk for recurrence: 1. Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS). 2. Skin cancer (non-melanoma or melanoma). 3. Non-invasive cervical cancer. 4. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents. 5. Localized prostate cancer (M0, N0) with a Gleason Score =7a, treated locally only (RP/RT/focal treatment). iii. Other malignancy that is considered at minimal risk of recurrence. b. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone >20 mg daily (or corticosteroid equivalent) to treat or control the autoimmune disease. c. Recent infection requiring systemic treatment that is ongoing or was completed =14 days before the first dose of study treatment, or any uncontrolled active systemic infection. d. Known bleeding disorders (eg, von Willebrand’s disease or hemophilia). e. Stroke or intracranial hemorrhage within 6 months prior to enrollment. f. Difficult to control hypertension (defined as requiring =3 hypertensive medications) or screening systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg. For participants whose screening blood pressure exceeds a systolic blood pressure of 160 mmHg or a diastolic blood pressure of 100 mmHg, the investigator should review and manage the participant appropriately according to individual practice. The participant may be rescreened if it can be demonstrated that the blood pressure reading was a single isolated elevation or is subsequently controlled and stable. g. History of myocardial infarction, ventricular arrhythmia, unstable angina, or acute coronary syndrome within 12 months prior to enrollment (if >1 year, cardiology consultation is recommended prior to study enrollment), 2. Known or suspected Richter’s transformation or CNS involvement, 5. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification (see Section 10.8). For participants who in the investigator’s opinion are considered to have a significant cardiac risk at baseline, the investigator should consider pursuing a cardiology evaluation before screening. It is the investigator’s responsibility to assess the risks and benefits of subsequent study enrolment, 10. Participant received prior systemic anticancer therapy (including but not limited to chemotherapy, targeted therapy, immunomodulating therapy, radiotherapy, and/or monoclonal antibody) for treatment of CLL or SLL, 20. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise their wellbeing) or that could prevent, limit, or confound the protocol-specified assessments
研究者
相似试验
已完成
不适用
ine Month Course of Anti-HIV Medications for People Recently Infected With HIVPER-121-07Division de SIDA de los Institutos Nacionales de Salud (USA),
已完成
不适用
A prospective multicenter cohort study for treatment outcome, QOL, cost and cost-effectiveness of R-CHOP therapy alone and radiation combination therapy in untreated adult primary diffuse large B-cell lymphoma.ntreated limited-stage DLBCJPRN-UMIN000026684Clinical Hematology Study Group of National Hospital Organization100
尚未招募
不适用
A randomized controlled trials of the effect of mBrain therapy with people with significant anxiety at 4 weeks after the intervention.anxietyACTRN12618001634268Professor Bruce Arroll116
已完成
不适用
Multicentre Non-interventional Study of Treatment Outcome in Heart Failure Patients with Hyperkalaemia under RAASi-treatment Receiving Veltassa in Routine PracticeE87.5HyperkalaemiaDRKS00014825Vifor Pharma Deutschland GmbH22
已完成
不适用
Multicenter retrospective study of treatment with recombinant human soluble thrombomoduin (rTM) in severe acute pancreatitis with disseminated intravascular coagulation (DIC)acute pancreatitisJPRN-UMIN000031768Osaka Saiseikai Nakatsu Hospital department of gastroenterology and hepatology600