EUCTR2014-003893-17-DE进行中（未招募）1 期
Combination of ibrutinib and bortezomib followed by ibrutinib maintenance to treat patients with relapsed and refractory mantle cell lymphoma; a multicenter Phase I/II trial
SAKK, Swiss Group for Clinical Cancer Research0 个研究点目标入组 49 人开始时间: 2017年7月24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
- 49
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
- •6.1.1 Patient must give written informed consent before registration
- •indicating that the patient understands the purpose of the procedures
- •required for the trial and is willing to participate in the trial.
- •6.1.2 Histologically confirmed mantle cell lymphoma with either
- •overexpression of cyclin D1 protein or evidence of t(11;14)(q13;q32)
- •assessed by cytogenetics, by fluorescence, in situ hybridization (FISH)
- •or by polymerase chain reaction (PCR).
- •6.1.3 Refractory or relapsed disease in need of systemic therapy after
- •pretreatment with non-bortezomib-containing chemotherapy (including
- •high-dose therapy plus autologous stem cell support; induction and
- •consolidation with high-dose chemotherapy is considered one line of
- •chemotherapy.)
- •6.1.4 At least one measurable lesion =11 mm in its greatest
- •transverse diameter measured with CT scan
- •(contrast enhanced) or MRI (in case of the disease cannot be
- •adequately imaged using CT and if contrast is not appropriate for
- •patients according to the treating physician).
- •6.1.5 WHO performance status 0-2 (see 0)
- •6.1.6 Age = 18 years
- •6.1.7 Adequate hematological values:
- •o Absolute neutrophil count (ANC) = 1.0 x 10^9/L independent of
- •growth factor support
- •o Platelets = 100 x 10^9/L or = 50 x 10^9/L if bone marrow
- •involvement independent of transfusion support in either situation,
- •o Hb = 80 g/L
- •6.1.8 Adequate hepatic function:
- •o Total bilirubin =1.5xupper limit of normal (ULN) unless bilirubin is
- •due to Gilbert`s syndrome = 5.0 x ULN
- •o Aspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT) =3xULN
- •6.1.9 Adequate renal function: Body surface area (BSA) corrected
- •creatinine clearance =40mL/min/1.73m^2 (calculated according to the
- •corrected formula of Cockcroft-Gault, see 0)
- •6.1.10 Women of childbearing potential and men who are sexually
- •active must be practicing a highly effective method of birth control
- •during and after the trial (see below) consistent with local regulations
- •regarding the use of birth control methods for patients participating in
- •clinical trials. Men must agree to not donate sperm
- •during and after the trial. These restrictions apply for
- •o Ibrutinib: 3 month after the last dose of trial drug for males and 1
- •month for females.
- •o Bortezomib: during trial treatment (for males and females): no
- •restrictions of birth control after last dose of trial drug. Donation of
- •sperm: 6 month after the last dose of trial drug.
- •6.1.11 Women of childbearing potential must have a negative serum
- •(beta-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test
- •at baseline. Women who are pregnant or breastfeeding are ineligible
- •for this trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- 另有 4 项未显示
排除标准
- •6.2.1 Prior therapy with ibrutinib or bortezomib
- •6.2.2 Adverse event neuropathy of prior therapy grade =2 (according
- •to CTCAE criteria Version 4.0) at registration
- •6.2.3 Previous malignancy within 5 years with the exception of
- •adequately treated in situ cervical cancer or localized non-melanoma
- •skin cancer.
- •6.2.4 Presence or history of CNS disease (either CNS lymphoma or
- •lymphomatous meningeosis)
- •6.2.5 Evidence of ongoing systemic infections of all kind
- •6.2.6 Exclusion of the following prior treatments prior to trial
- •registration
- •o major surgery within 4 weeks
- •o concurrent treatment with other experimental drugs or treatment in
- •a clinical trial within 30 days.
- •o treatment with chemotherapy and radiotherapy within 3 weeks
- •o vaccinated with live, attenuated vaccines within 4 weeks
- •6.2.7 History of stroke or intracranial hemorrhage within 6 months
- •prior to trial registration.
- •6.2.8 Requires anticoagulation with warfarin or equivalent vitamin K
- •antagonists (e.g. phenprocoumon)
- •6.2.9 Requires treatment with strong or moderate CYP3A inhibitors
- •(see http://medicine.iupui.edu/clinpharm/ddis/main-table and also
- •chapter 9.11.1.2 of the study protocol)
- •6.2.10 Clinically significant cardiovascular disease such as congestive
- •heart failure NYHA III or IV (as defined by the New York Heart
- •Association Functional Classification), uncontrolled or
- •symptomatic arrhythmias, significant QT-prolongation, unstable angina
- •pectoris myocardial infarction within 6 months of prior to registration,
- •6.2.11 Known history of human immunodeficiency virus (HIV) or
- •active Hepatitis C virus or active Hepatitis B virus infection or any
- •uncontrolled active systemic infection requiring treatment.
- •6.2.12 Prior allogeneic bone marrow or solid organ transplantation
- •6.2.13 Any life-threatening illness, medical condition, or organ system
- •dysfunction which, in the investigator's opinion,
- •o could impair the ability of the patient to participate in the trial
- •o could compromise the patient's safety,
- •o could interfere with the absorption or metabolism of ibrutinib
- •capsules, or
- •o could put the trial outcomes at undue risk
- •o could prevent compliance with trial treatment.
- •6.2.14 Psychiatric disorder precluding understanding of trial
- •information, giving informed consent, or interfering with compliance
- •for oral drug intake.
- •6.2.15 Known hypersensitivity to trial drug(s) or hypersensitivity to
- •any other component of the trial drugs.
- •6.2.16 Any concomitant drugs contraindicated for use with the trial
- •drugs according to the approved product information.
- •6.2.17 Any psychological, familial, sociological or geographical
- •condition potentially hampering compliance with the trial protocol and follow-up.
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