2023-509354-58-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination with Acalabrutinib (ACP-196) in Subjects with Previously Untreated Mantle Cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 56
- 主要终点
- The primary endpoint of the study is PFS as assessed by IRC per the Lugano Classification for NHL. The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus BR) and Arm 2 (placebo plus BR).
研究概览
简要总结
To evaluate the efficacy of acalabrutinib (ACP-196) in combination with bendamustine and rituximab (BR) compared with placebo in combination with BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non Hodgkin Lymphoma (NHL) (Cheson 2014) in subjects with previously untreated mantle cell lymphoma (MCL)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men and women, ≥65 years of age.
- •Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5).
- •MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
- •Presence of radiologically measurable lymphadenopathy and/or extranodal lymphoid malignancy.
- •ECOG performance status of ≤
- •Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest.
- •Men must agree to refrain from sperm donation during the study and for 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest.
- •Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
排除标准
- •History of prior malignancy except for the following: a. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician. Note: Provided they meet other eligibility criteria, subjects who are receiving hormonal therapy alone are allowed to enroll on study. b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer. c. Adequately treated carcinoma in situ without current evidence of disease.
- •Prothrombin time/INR or aPTT (in the absence of a Lupus anticoagulant) > 2.0 x ULN. Exception: Subjects receiving warfarin are excluded; however, those receiving other anticoagulant therapy who have a higher INR/aPTT may be permitted to enroll to this study after discussion with the medical monitor.
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- •Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
- •Known history of infection with HIV.
- •Ongoing immunosuppressive therapy, including systemic (eg, IV or oral) corticosteroids within 2 weeks before the first dose of study drug. Note: Subjects may use topical or inhaled corticosteroids or low dose steroids (≤ 20 mg prednisone equivalent/day for ≤ 2 weeks) as a therapy for comorbid conditions. During study participation, subjects may also receive systemic (eg, IV or oral) corticosteroids as needed for treatment emergent comorbid conditions.
- •Known history of anaphylaxis or hypersensitivity to bendamustine, rituximab, or any of their components.
- •Subjects for whom the goal of therapy is tumor debulking before stem cell transplant.
- •Any history of CNS lymphoma or leptomeningeal disease.
- •Uncontrolled AIHA or ITP.
- •Major surgical procedure within 28 days before first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- •Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
- •ANC < 1.0 x 109/L or platelet count < 75 x 109/L; for subjects with disease involvement in the bone marrow, ANC < 0.75 x 109/L or platelet count < 50 x 109/L. Subjects will only be considered eligible if peripheral blood counts can be maintained independent of growth factors or transfusions during the screening period.
- •Total bilirubin > 1.5 x ULN; or AST or ALT > 2.5 x ULN.
- •Estimated creatinine clearance of < 50 mL/min, calculated using the formula of Cockcroft and Gault [(140-age)•mass (kg)/(72•creatinine mg/dL)•multiply by 0.85 if female].
结局指标
主要结局
The primary endpoint of the study is PFS as assessed by IRC per the Lugano Classification for NHL. The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus BR) and Arm 2 (placebo plus BR).
The primary endpoint of the study is PFS as assessed by IRC per the Lugano Classification for NHL. The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus BR) and Arm 2 (placebo plus BR).
次要结局
- Investigator-assessed PFS per the Lugano Classification for NHL
- Investigator-assessed ORR (CR+PR) per the Lugano Classification for NHL
- IRC-assessed ORR (CR+PR) per the Lugano Classification for NHL
- OS
- IRC-assessed DOR per the Lugano Classification for NHL
- IRC assessed TTR per the Lugano Classification for NHL
- IRC-assessed ORR (CR + PR) per Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
- PRO as measured by change in scores from baseline to each assessment using the FACT-Lym scale
- PRO as measured by change in scores from baseline to each assessment using the EQ-5D-5L index score
研究者
Clinical Study Information Center
Scientific
Acerta Pharma B.V.
研究点 (56)
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