EUCTR2016-003202-14-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Subjects with Follicular Lymphoma - PERSPECTIVE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •Disease Related
- •1. Subjects with histologically documented follicular lymphoma CD20+ (Grade 1, 2 or 3a) according to World Health Organization (WHO) criteria; Ann Arbor Stage II, III or IV disease.
- •* Prior to randomization, diagnosis must be confirmed by local pathology report stating a diagnosis of follicular lymphoma. If the report from the local laboratory is not available or insufficient, the diagnosis must be confirmed by the central pathology laboratory.
- •2. At least one two-dimensionally measurable lesion =2.0 cm in longest diameter (LDi) by contrast-enhanced CT scan. Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead.
- •3. Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities that make them a candidate to receive single-agent rituximab therapy:
- •* Creatinine clearance 30-59 mL/min (by Cockcroft-Gault). Alternatively, creatinine clearance may be calculated based on a 24-hour urine collection.
- •* ECOG performance status score of 2
- •4. In need of systemic therapy as evidenced by meeting one or more of the following Groupe d’Etude des Lymphomes Folliculaire (GELF) criteria (Solal-Céligny 1998):
- •* Involvement of =3 nodal sites, each with a diameter of >3 cm
- •* Any nodal or extranodal tumor mass with a diameter of >7 cm
- •* B symptoms (ie, fever, night sweats or weight loss)
- •* Splenomegaly
- •* Pleural effusions or peritoneal ascites
- •* Thrombocytopenia (platelet count <100 x 10^9/L)
- •* Peripheral blood involvement (>5.0 x 10^9/L malignant cells)
- •5. Adequate hematologic function defined as:
- •* Hemoglobin =8.0 g/dL
- •* Platelet count =50 x 10^9/L (50,000 cells/mm3)
- •* Absolute neutrophil count (ANC) =1.0 x 10^9/L (1,000 cells/mm3)
- •6. Adequate renal and hepatic function defined as:
- •* Estimated Creatinine Clearance =30 mL/min (Cockcroft-Gault)
- •* Serum aspartate transaminase (AST) and alanine transaminase (ALT) =3 x upper limit of normal (ULN)
- •* Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome such that bilirubin =3 x ULN or is of non-hepatic origin)
- •7. PT/INR <1.5 x ULN (unless treated with warfarin or other vitamin K antagonists such that INR =3.0) and PTT (aPTT) <1.5 x ULN
- •Demographic
- •8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- •Ethical/Other
- •9. Female subjects of reproductive potential must have a negative urine/serum pregnancy test upon study entry. Female subjects who are of non-reproductive potential (ie, post menopausal by history - no menses for =1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy) are exempt from pregnancy testing.
- •10. Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (eg, condoms, cervical ring, sponge, etc) during the period of therapy. For female subjects, these birth control requirements must be adhered to for 30 days after the last dose of ibrutinib/placebo and 12 months after the last dose of rituximab, whichever is later. For male subjects, these birth control requirements must be adhered to for 90 days after the last dose of ibrutinib/placebo.
- •Are the trial subjects under 18? no
- •Number of subjects for th
排除标准
- •Disease-Related
- •1. Transformed lymphoma; if clinical evidence of transformed lymphoma is present (high lactate dehydrogenase [LDH] and/or high maximum standard uptake value [SUVmax] of a lymph node/lesion on positron emission tomography [PET] scanning), transformation should be ruled out by biopsy of the suspicious lymph node/lesion.
- •2. Prior treatment for follicular lymphoma (eg, systemic anti-cancer therapy or involved site radiotherapy).
- •3. Medically apparent central nervous system lymphoma or leptomeningeal disease.
- •Concurrent Conditions
- •4. History of other malignancies, except:
- •* Malignancy treated with curative intent and with no known active disease present for =3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
- •* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •* Adequately treated carcinoma in situ without evidence of disease.
- •5. Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of >20 mg/day of prednisone or equivalent) within 28 days of the first dose of study drug. For indications other than lymphoma or management of lymphoma-related symptoms, the following are exceptions to this criterion:
- •* Intranasal, inhaled, topical corticosteroids or local corticosteroid injections (eg, intra-articular injection)
- •* Systemic corticosteroids at doses not to exceed 20 mg/day of prednisone or its equivalent
- •* Corticosteroids as pre-medication for hypersensitivity reactions (eg, CT scan pre-medication)
- •6. Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
- •7. Known bleeding disorders (eg, von Willebrand’s disease or hemophilia).
- •8. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- •9. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded. In equivocal cases, hepatitis B or C PCR may be performed and must be negative for enrollment.
- •10. Any uncontrolled active systemic infection or recent infection requiring intravenous antibiotic treatment that was completed =14 days before the first dose of study drug.
- •11. Major surgery within 4 weeks of first dose of study drug.
- •12. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk.
- •13. Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
- •14. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
- •15. Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab.
- •16. Prior use of an anti-CD20 agent
研究者
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