2023-504044-34-00招募中2 期
Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 213
- 试验地点
- 42
- 主要终点
- Best ORR by investigator assessment
研究概览
简要总结
To evaluate the efficacy of I+V and ibrutinib monotherapy regimens using a tailored treatment approach in which dosing of ibrutinib is either proactively reduced or reactively modified (per the label) in response to AEs, compared with clinical trial-based historical controls of ibrutinib monotherapy and I+V
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of CLL/SLL that meets iwCLL diagnostic criteria
- •For I+V cohorts: ECOG performance status of 0-
- •For ibrutinib monotherapy cohorts: ECOG performance status of 0-2
- •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.
- •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
- •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)
- •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
- •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:
- •Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS).
- •Skin cancer (non-melanoma or melanoma).
- •Non-invasive cervical cancer.
- •Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
- •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)
- •Known or suspected Richter’s transformation or CNS involvement
- •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
- •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
- •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
结局指标
主要结局
Best ORR by investigator assessment
Best ORR by investigator assessment
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (42)
Loading locations...
相似试验
尚未招募
2 期
A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström MacroglobulinemiaNCT07259122Institute of Hematology & Blood Diseases Hospital, China43
招募中
4 期
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell LymphomaHemophagocytic LymphohistiocytosisNCT07270835The First Affiliated Hospital of Soochow University40
招募中
2 期
Multicenter, open-label, phase II study in patients with immunoglobulin M monoclonal gammopathy of unknown significance and Myelin Associated Glycoprotein antibodies related polyneuropathy and Zanubrutinib Treatment2023-505933-29-00University Medical Center Utrecht42
招募中
2 期
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk DiseaseNCT07272499Ruijin Hospital25
招募中
2 期
An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.NCT07282262Peking Union Medical College Hospital300