EUCTR2018-002364-44-PT进行中（未招募）1 期
MALIBU trial - Phase II study of combination ibrutinib and rituximab in untreated marginal zone lymphomas - Combination of ibrutinib and rituximab in untreated MZ
IELSG - INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP0 个研究点目标入组 175 人开始时间: 2020年8月4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
- 175
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
- •Chemotherapy and immunotherapy-naïve, symptomatic and in need of treatment patients, with histologically proven CD20-positive MZL, not eligible for local therapy, including:
- •1. EMZL (MALT Lymphoma) patients with MALT-IPI score 1-3 in need
- •of systemic therapy.Either de novo or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site with MALT- IPI score 1-3 at the time of study entry.
- •1.1. The following patients with gastric MALT Lymphoma can be
- •a) H. pylori-negative cases, either de novo (non pretreated) or at
- •relapse following local therapy (i.e., surgery, radiotherapy or
- •antibiotics)
- •b) H. pylori-positive cases at diagnosis, who either first line
- •antibiotics or further local treatment (surgery or radiotherapy),
- •including patients with:
- •Clinical (endoscopic) and histological evidence of disease
- •progression at any time post H. pylori eradication;
- •Clinical (endoscopic) and histological relapse (without H.
- •pylori re-infection), after a remission patients;
- •Persistent (stable) lymphoma at = 1 year post H. pylorieradication.
- •1.2. Similar consideration may be applied to patients with ocular adnexal lymphoma treated with antibiotics.
- •2. SMZL patients in need of therapy.Either de novo or relapsed following local therapy [including surgery and antiviral therapy for HCV. Patient must have a symptomatic disease requiring treatment and be not eligible for splenectomy or not willing to undergo splenectomy.
- •2.1. Patients with SMZL can be entered if any of the following criteria is present
- •a) bulky progressive or painful splenomegaly:
- •b) enlarged lymph nodes or involvement of extranodal sites with
- •or without cytopenias, i.e. involvement of =3 nodal sites, each
- •with a diameter of =3 cm. Any nodal tumor mass with a diameter
- •of =7 cm (GELF criteria, as adopted in follicular lymphoma)
- •c) one of the following symptomatic/progressive cytopenias
- •Hgb < 10 g/dL; ANC < 1000/µL; PLT < 80000/µL whatever the reason (autoimmune or hypersplenism or bone marrow infiltration)
- •2.2. Splenectomised patients with rapidly raising lymphocyte counts,
- •lymphadenopathy or involvement of extranodal sites can be
- •2.3. SMZL with concomitant HCV infection who have not responded to
- •or are relapsed after antiviral therapy can be entered.
- •3 NMZL patients in need of therapy
- •Either, de novo presenting with disseminated disease or relapsed
- •after local radiotherapy or following antiviral therapy for HCV
- •Localized nodal MZL is not eligible
- •4. Measurable or evaluable disease. Measurable disease in at least
- •two perpendicular dimensions on an imaging scan is defined as:
- •lymph node or nodal mass bi-dimensional measurement with > 1.5
- •cm in longest transverse diameter or the short diameter must
- •measure > 10 mm regardless of the longest transverse diameter.
- •5. Ann Arbor II-IV. Stage I disease may be eligible only
- •if not candidate to local therapy (surgery or radiotherapy).
- •6. Age = 18
- •7. Life expectancy of at least 1 year
- •8. ECOG Performance status 0-2
- •9. Adequate bone marrow function, eg. ANC=1.0x109/L, independent
- •of growth factor support, unless due to lymphoma involvement and
- •PLT =100x109/L (or = 50 x 109/L in case of bone marrow
- •involvement) independent of transfusion support. The minimum
- •time for transfusion is 3 months before inclusion
- •10. Adequate kidney (serum creatinine =1,5 x upper normal) and liver
- •function (ASAT/ALAT =2,5 upper normal, total bilirubin =2,0 x upper
排除标准
- •1. Any type of lymphoma other than MZL (including MZL with
- •histologic transformation to high-grade lymphoma).
- •2. Localized (stage IE and IIE) MALT lymphoma, for example gastric,
- •ocular and cutaneous lymphoma, that may benefit from local
- •therapy only (surgery or radiotherapy).
- •3. Known CNS involvement of MZL.
- •4. Any previous systemic treatment with immunotherapy or
- •chemotherapy or with BTK inhibitors.
- •5. Major surgery within 4 weeks prior to registration.
- •6. History of stroke or intracranial bleeding within 6 months.
- •7. Known bleeding diathesis (eg, von Willebrand’s disease) or
- •hemophilia.
- •8. Concurrent use of warfarin or other vitamin K antagonists.
- •9. Concurrent use of strong cytochrome P450 (CYP)3A4/5 inhibitors.
- •10. Any life-threatening illness, medical condition, or organ system
- •dysfunction which, in the investigator’s opinion, could compromise
- •the subject’s safety, interfere with the absorption or metabolism of
- •ibrutinib capsules, or put the study outcomes at undue risk.
- •11. International normalized ratio (INR) or prothrombin time (PT) =1.5
- •ULN. Partial thromboplastin time (PTT) or activated PTT (aPTT)
- •=1.5 ULN unless due to lupus anticoagulant.
- •12. Vaccinated with live, attenuated vaccines within 4 weeks prior to
- •enrollment.
- •13. Clinically significant hypersensitivity (e.g., anaphylactic or
- •anaphylactoid reactions to the compound of ibrutinib and/or
- •rituximab themselves or to the excipients in their formulation).
- •14. Positive test results for chronic HBV infection (defined as positive
- •HBsAg serology).
- •15. Patients with occult or prior HBV infection (defined as negative
- •HBsAg and positive total HBcAb) may be included if HBV DNA is
- •undetectable, provided that they are willing to undergo monthly
- •DNA testing and taking specific antiviral prophylaxis, according to
- •local policy. Patients who have protective titers of hepatitis B
- •surface antibody (HBsAb) after vaccination are eligible.
- •16. Positive test results for hepatitis C. Patients positive for HCV
- •antibody are eligible only if PCR is negative for HCV RNA
- •17. HIV infection or immunodeficiency.
- •18. Active, severe infections
- •19. Pregnancy or breastfeeding.
- •20. Clinically significant cardiovascular diseases such as uncontrolled
- •or symptomatic arrhythmias, congestive heart failure, or myocardial
- •infarction within 6 months of screening, or any Class 3 (moderate)
- •or Class 4 (severe) cardiac disease as defined by the New York
- •Heart Association Functional Classification.
- •21. Any serious medical or psychiatric illness likely to interfere with
- •participation in this clinical study.
- •22. Prior history of malignancies other than MZL within 3 years, with the
- •exception of adequately treated cervical carcinoma in situ or
- •localized non-melanoma skin cancer.
- •23. Current enrolment or participation in another therapeutic clinical trial within 28 days prior to treatment start
研究者
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