EUCTR2013-000506-37-CZ进行中（未招募）1 期
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7月18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
- 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
- •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)
- 另有 12 项未显示
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
- •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.
研究者
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