Subcutaneous Bortezomib, Cyclophosphamide and Rituximab (BCR) versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for initial therapy of Waldenstrom macroglobulinaemia: a randomised phase II study. - R2W: Randomised phase 2 trial in Waldenstrom macroglobulinaemia

niversity College London0 个研究点目标入组 56 人开始时间: 2012年7月13日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•I. Age = 18 years
•II. Confirmed diagnosis of WM with measurable IgM paraprotein
•III.Previously untreated disease at any stage requiring therapy at the discretion of the treating physician. Suggested criteria for initiating treatment include:
•a.haematological suppression to Hb <10 g/dl, or neutrophils <1.5x10(9)/l or platelets <150x10(9)/l
•b.clinical evidence of hyperviscosity
•c.bulky lymphadenopathy and/or bulky splenomegaly
•d.presence of B symptoms
•IV.No previous chemotherapy
•V.Performance status grade 0 - 2
•VI.Life expectancy of greater than 6 months
•VII.Informed consent
•VIII.Agreed compliance with recommended contraceptive precautions where appropriate
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 36

•I. Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein
•II. Severe pre-existing neuropathy (> grade 2)
•III.Autoimmune cytopenias
•IV. Evidence of active Hepatitis B or C infection
•V. Serological positivity for HIV
•VI. Pregnant or lactating women
•VII.Life expectancy severely limited by other illness
•VIII.Renal failure (creatinine clearance <30 ml/min)
•IX. Severe impairment of liver function: alkaline phosphatase/bilirubin >2.5xULN, ALT/AST >2.5xULN not related to lymphoma
•X. History of allergic reaction to compounds containing boron or mannitol
•XI.Known hypersensitivity to murine compounds.
•XII.Diagnosed or treated for a malignancy other than WM within 5 years with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin or any other in situ malignancy
•XIII.Active systemic infection requiring treatment
•XIV. Concurrent treatment with another investigational agent
•XV. Severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease

发起方

niversity College London