EUCTR2013-000506-37-IT进行中（未招募）不适用
Efficacy of first line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for patients with Waldenström's Macroglobulinemia
niversity Hospital Ulm0 个研究点目标入组 384 人开始时间: 2014年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 384
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
- •A) Clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Pathological diagnosis has to occur before study inclusion and randomization. In addition, pathological specimens have to be sent to the national pathological reference center at study inclusion and randomization. The positivity for CD20 can be assumed from any previous bone marrow immunohistochemistry or flow cytometry analysis performed up to 6 months prior to enrollment. Inclusion in the study will be based on morphological and immunological criteria. Immunophenotyping will be performed in each center and saved locally. Flow cytometry of bone marrow and blood cells will include at least one double staining and assess the expression of the following antigens: surface immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically similar to WM cells may be included after ruling out other low-grade B-cell malignancies.
- •B) Patients must have at least one of the following critera to initiate treatment as defined by Consensus Panel Two” recommendations from the Second International Workshop on Waldenström Macroglobulinemia.
- •a) Recurrent fever, night sweats, weight loss, fatigue
- •b) Hyperviscosity
- •c) Lympadenopathy which is either symptomatic or bulky (=5cm in maximum diameter)
- •d) Symptomatic hepatomegaly and/or splenomegaly
- •e) Symptomatic organomegaly and/or organ or tissue infiltration
- •f) Peripheral neuropathy due to WM
- •g) Symptomatic cryoglobulinemia
- •h) Cold agglutinin anemia
- •i) IgM related immune hemolytic anemia and/or thrombocytopenia
- •j) Nephropathy related to WM
- •k) Amyloidosis related to WM
- •l) Hemoglobin =10g/dL
- •m) Platelet count <100x109/L
- •n) Serum monoclonal protein >5g/dL, even with no overt clinical symptoms
- •C) Cumulative illness rating scale (CIRS) score less than 6 (see annex).
- •D) World Health Organization (WHO)/ECOG performance status 0 to 2.
- •E) Other criteria
- •a) Age = 18 years
- •b) Life expectancy >3 months.
- •c) Baseline platelet count =50x109/L (if not due to BM infiltration by the lymphoma), absolute neutrophil count =0.75x109/L.
- •d) Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment:
- •- ASAT (SGOT): =3 times the upper limit of institutional laboratory normal value
- •- ALAT (SGPT): =3 times the upper limit of institutional laboratory normal value
- •- Total Bilirubin: =20 mg/L or 2 times the upper limit of institutional laboratory normal value, unless clearly related to the disease (except if due to Gilbert’s syndrome)
- •- Serum creatinine = 2mg/dl
- •F) Premenopausal fertile females must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •G) Men must agree not to father a child for the duration of therapy and 6 months after and must agree to advice a female partner to use a highly effective method of birth control.
- •H) Voluntary written informed consent before performance of any study-related procedure not p
排除标准
- •Prior systemic treatment of the WM (plasmapheresis and short – term administration of corticosteroids < 4 weeks administered at a dose equivalent to < 20 mg/day prednisone is allowed)
- •Patient with hypersensitivity to dexamethasone.
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Uncontrolled bacterial, viral or fungal infection
- •Active HIV, HBV or HCV infection
- •Known interstitial lung disease
- •Prior allergic reaction or severe anaphylactic reaction related to humanized or murine monoclonal antibody.
- •Central Nervous System involvement by lymphoma
- •Prior history of malignancies unless the subject has been free of the disease for = 5 years. Exceptions include the following:
- •- Basal cell carcinoma of the skin,
- •- Squamous cell carcinoma of the skin,
- •- Carcinoma in situ of the cervix,
- •- Carcinoma in situ of the breast,
- •- Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).
- •Uncontrolled illness including, but not limited to:
- •- Uncontrolled diabetes mellitus (as indicated
- •by metabolic derangements and/or severe diabetes mellitus related uncontrolled organ complications)
- •- Chronic symptomatic congestive heart failure (Class NYHA III or IV).
- •- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- •- Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
- •- Known pericardial disease
- •Subjects with = Grade 2 neuropathy.
- •Women who are pregnant as well as women who are breast-feeding and do not consent to discontinue breast-feeding.
- •Participation in another clinical trial within 4 weeks before randomization in this study
- •No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
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