EUCTR2020-004554-30-CZ进行中（未招募）1 期
A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
oxo Oncology Inc0 个研究点目标入组 250 人开始时间: 2021年2月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age 18 or older per local regulations at time of enrollment.
- •2.Confirmed diagnosis by redacted local laboratory report of CLL/SLL
- •as defined by iwCLL 2018 criteria, including the following:
- •a)B-cells coexpressing the surface antigen CD5 together with at least
- •one B-cell antigen(CD19, CD20, CD23) and either ? or?? light-chain
- •restricted.
- •b) = 5 × 109 B lymphocytes/L (5000/µL) in the peripheral blood. For
- •SLL patients, history of = 5 × 109 B lymphocytes/L (5000/µL) in the
- •peripheral blood is allowed.
- •c)Prolymphocytes may comprise = 55% of blood lymphocytes.
- •3.A requirement for therapy consistent with iwCLL 2018 criteria for
- •initiation of therapy such that at least 1 of the following should be met:
- •a)Evidence of progressive marrow failure as manifested by the
- •development of, or worsening of, anemia (such as hemoglobin < 10
- •g/dL) and/or thrombocytopenia(such as platelets = 100 × 109/L).
- •b)Massive (i.e., spleen edge = 6 cm below the left costal margin) or
- •progressive or symptomatic splenomegaly(= 13 cm).
- •c)Massive nodes (i.e., = 10 cm in longest diameter) or progressive or
- •symptomatic lymphadenopathy.
- •d)Progressive lymphocytosis with an increase of > 50% over a 2-
- •month period or lymphocyte doubling time < 6 months. Factors
- •contributing to lymphocytosis other than CLL/SLL (e.g., infections,
- •steroid administration)should be excluded.
- •e)Autoimmune complications including anemia or thrombocytopenia
- •poorly responsive to corticosteroids.
- •f)Symptomatic or functional extranodal involvement(e.g., skin,
- •kidney, lung, spine).
- •g)Disease-related symptoms (also known as B-symptoms) as defined
- •by any of the following:
- •i)Unintentional weight loss = 10% within the previous 6 months.
- •ii)Significant fatigue(i.e., Eastern Cooperative Oncology Group [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 or more weeks without evidence of
- •iv)Night sweats for = 1 month without evidence of infection.
- •4.Known 17p deletion status(wildtype for 17p locus or positive for 17p
- •deletion)by FISH see Section 1.2.2.
- •5.Previously treated with a covalent BTK inhibitor, investigational or
- •approved, and either alone or in combination with other agents. Patients
- •may have received an unlimited number of lines of prior therapy.
- •6.Eastern Cooperative Oncology Group(ECOG)0-2.
- •7.Must have adequate organ function, as defined below. These values
- •must be met during the Screening Period. Results from the most recent
- •assessment will be used for eligibility.
- •8.Patients are required to have had the following washout periods
- •prior to planned C1D1:
- •a)Targeted agents or cytotoxic chemotherapy: 5 half-lives or 2 weeks,
- •whichever is shorter
- •b)Anticancer therapeutic monoclonal antibodies: 4 weeks; patients
- •who crossover are not required to observe this washout period
- 另有 11 项未显示
排除标准
- •1. Known or suspected Richter's transformation to diffuse large B-cell
- •lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at
- •any time preceding enrollment.
- •2. Known or suspected history of central nervous system (CNS)
- •involvement by CLL/SLL.
- •3. Patients who experienced a major bleeding event on a prior BTK
- •inhibitor. Refer to Protocol for definition of major bleeding.
- •4. Active second malignancy; patients with treated second malignancy
- •who are in remission with life expectancy > 2 years and with
- •documented Sponsor approval are eligible.
- •5. Major surgery, within 4 weeks of planned start of study treatment.
- •6. History of or ongoing drug-induced pneumonitis.
- •7. Ongoing drug-induced liver injury, primary biliary cirrhosis and/or
- •extrahepatic obstruction caused by cholelithiasis and cirrhosis of the
- •8. History of allogeneic or autologous SCT or CAR-T therapy within the
- •past 60 days.
- •9. Active uncontrolled auto-immune cytopenia (e.g., autoimmune
- •hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- •not on a stable regimen and dose for at least 4 weeks prior to study
- •enrollment.
- •10. Significant cardiovascular disease. For definitions see Protocol.
- •11. Prolongation of the QT interval corrected (QTc) for heart rate using
- •Fridericia's Formula (QTcF) > 470 msec on at least 2 of 3 consecutive
- •electrocardiograms (ECGs), and mean QTcF > 470 msec on all 3 ECGs,
- •during Screening.
- •a) QTcF is calculated using Fridericia's Formula (QTcF = QT/(RR^0.33)
- •b) Correction of suspected drug-induced QTcF prolongation or
- •prolongation due to electrolyte abnormalities can be attempted at the
- •Investigator's discretion, and only if clinically safe to do so with either
- •discontinuation of the offending drug or switch to another drug not
- •known to be associated with QTcF prolongation or electrolyte
- •supplementation.
- •c) Correction of QTc for underlying bundle branch block (BBB)
- •permissible.
- •12. Hepatitis B or hepatitis C testing indicating active/ongoing infection.
- •Refer to Protocol for screening laboratory tests.
- •13. Known active cytomegalovirus (CMV) infection. Patients with
- •negative status are eligible.
- •14. Evidence of other clinically significant uncontrolled condition(s)
- •including, but not limited to, uncontrolled systemic infection (viral,
- •bacterial, or fungal) or other clinically significant active disease process
- •which in the opinion of the Investigator and Medical Monitor, may pose a
- •risk for patient participation. Screening for chronic conditions is not
- •15. Known Human Immunodeficiency Virus (HIV) infection, regardless of
- •CD4 count. Patients with unknown or negative status are eligible.
- •16. Clinically significant active malabsorption syndrome or other
- •condition likely to affect gastrointestinal (GI) absorption of the oraladministered
- •study treatments.
- •17. Ongoing inflammatory bowel disease.
- •18. Prior exposure to non-covalent (reversible) BTK inhibitor.
- 另有 10 项未显示
研究者
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