EUCTR2017-000129-12-CZ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 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)
- •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 enrollment
- •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)
- •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 origin)
- •8. Prothrombin time (PT) or International normal ratio (INR) <1.5 x
- 另有 10 项未显示
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 disease.
- •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
- •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 excluded.
- •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 undue risk
- •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
- 另有 14 项未显示
研究者
相似试验
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-NLPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMantle Cell LymphomaEUCTR2017-000129-12-DEPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-BEPharmacyclics LLC362
进行中（未招募）
1 期
Research study of Ibrutinib in Combination with Venetoclax in patients with Mantle Cell LymphomaMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Mantle Cell LymphomaEUCTR2017-000129-12-GBPharmacyclics LLC362
招募中
3 期
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell LymphomaNon-Hodgkin lymphomaMantle Cell lymphomaNL-OMON52949Pharmacyclics18