EUCTR2017-000129-12-NL进行中（未招募）1 期
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 362
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
- •For SRI and Randomization Phase
- •Disease-Related
- •Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR).
- •At least 1 measurable site of disease on cross-sectional imaging that is =2.0 cm in the longest diameter and measurable in 2 perpendicular dimensions per CT
- •At least 1, but no more than 5, prior treatment regimens for MCL including at least 1 prior rituximab/anti-CD20 containing regimen
- •Failure to achieve at least partial response (PR) with, or documented disease progression after, the most recent treatment regimen
- •Subjects must have adequate fresh or paraffin embedded tissue.
- •Adequate hematologic function
- •Adequate hepatic and renal function
- •Demographic
- •Men and women = 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =2
- •For Treatment-naive Open-label Arm:
- •1. Pathologically confirmed treatment-naive MCL (tumor tissue), with documentation of either
- •overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20,
- •PAX5, CD5) or evidence of t(11;14), as assessed by cytogenetics, fluorescent in situ
- •hybridization (FISH), or polymerase chain reaction (PCR)
- •A report from the local laboratory is acceptable if available; however, it must be reviewed
- •and approved by the central pathology laboratory to verify the above criteria prior to
- •If the report from the local laboratory is not available, a tumor block or slides must be sent
- •to the central pathology laboratory for confirmation of the MCL diagnosis prior to
- •enrollment.
- •2. Men and women =18 years of age, with a TP53 mutation
- •3. At least 1 measurable site of disease that is =2.0 cm in the longest diameter and measurable in
- •2 perpendicular dimensions per CT
- •4. Subjects must have adequate fresh or paraffin-embedded tissue
- •5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of = 2
- •6. Adequate hematologic function independent of transfusion and growth factor support for at
- •least 7 days prior to first dose, with the exception of pegylated G-CSF (pegfilgrastim) and
- •darbepoeitin which require at least 14 days prior to the first dose defined as:
- •Absolute neutrophil count (ANC) >1000 cells/mm3 (1.0 x 109/L)
- •Platelet count >50,000 cells/mm3 (50 x 109/L)
- •Hemoglobin >8.0 g/dL
- •7. Adequate hepatic and renal function defined as:
- •Serum aspartate transaminase (AST) or alanine transaminase (ALT) =3.0 x upper limit of
- •normal (ULN)
- •Estimated Creatinine Clearance (CrCl) =30 mL/min (Cockcroft-Gault)
- •Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic
- •8. Prothrombin time (PT) or International normal ratio (INR) <1.5 x upper limit of normal
- •(ULN) and PTT (activated partial thromboplastin time [aPTT]) <1.5 x ULN (unless
- •abnormalities are unrelated to coagulopathy or bleeding disorder). When treated with warfarin
- •or other vitamin K antagonists, then INR =3.0
- •9. Male and female subjects of reproductive potential who agree to use both a highly effectivemethod of birth control (eg, implants, injectables, combined oral contraceptives, some
- •intrauterine devices [IUDs], complete abstinence5, or sterilized partner) and a barrier method
- •(eg, condoms, cervical ring, sponge, etc) during the period of th
排除标准
- •For SRI and Randomization Phase
- •Disease-Related
- •History or current evidence of central nervous system lymphoma
- •Concurrent Conditions
- •Concurrent enrollment in another therapeutic investigational study or prior therapy with ibrutinib or other BTK inhibitors
- •Prior treatment with venetoclax or other BCL2 inhibitors
- •Anticancer therapy including chemotherapy, radiotherapy, small molecule and investigational agents =21 days prior to receiving the first dose of study drug
- •Treatment with any of the following within 7 days prior to the first dose of study drug:
- •o moderate or strong cytochrome P450 3A (CYP3A) inhibitors
- •o moderate or strong CYP3A inducers
- •For Treatment-naive Open-label Arm:
- •1. Blastoid variant of MCL
- •2. History or current evidence of central nervous system lymphoma
- •3. Concurrent enrollment in another therapeutic investigational study or prior therapy, including
- •ibrutinib or other BTK inhibitors
- •4. Prior treatment with venetoclax or other BCL2 inhibitors
- •5. 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
- •Adequately treated carcinoma in situ without evidence of disease.
- •6. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug
- •7. Clinically significant infection requiring IV systemic treatment that was completed =14 days
- •before the first dose of study drug
- •8. Any uncontrolled active systemic infection
- •9. Known bleeding disorders (eg, von Willebrand’s disease or hemophilia)
- •10. History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- •11. Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus
- •(HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, or
- •hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before
- •enrollment. Those who are hepatitis B surface antigen (HBsAg) or PCR positive will be
- •12. Major surgery within 4 weeks of the first dose of study drug.
- •13. 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
- •14. 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
- •15. Unable to swallow capsules or tablets, 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
- •16. Treatment with any of the following within 7 days prior to the first dose of study drug:
- •Moderate or strong cytochrome P450 3A (CYP3A) inhibitors
- •Moderate or strong CYP3A inducers
- •17. Administration or consumption of any of the following within 3 days prior to the first dose
- •of study drug:
- •grapefruit or grapefruit products
- •Seville oranges (including marmalade containing Seville oranges)
- •star fruit
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研究者
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