EUCTR2019-001261-33-GB进行中（未招募）1 期
Randomised phase II/III study of Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as initial therapy for Waldenström's macroglobulinaemia - RAINBOW
niversity College London0 个研究点目标入组 148 人开始时间: 2019年7月29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
- 148
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
- •1.Patients =18 years
- •2.Confirmed diagnosis of WM (according to consensus panel / WHO criteria) with measurable IgM paraprotein
- •3.Previously untreated disease at any stage requiring therapy at the discretion of the treating physician. Suggested criteria for initiating treatment include:
- •- haematological suppression to Hb <10g/dl, or neutrophils <1.5x109/l or platelets <150x109/l
- •- clinical evidence of hyperviscosity
- •- bulky lymphadenopathy and/or bulky splenomegaly
- •- presence of B symptoms
- •4.No previous chemotherapy (prior plasma exchange and steroids are permissible)
- •5.Eastern Cooperative Oncology Group (ECOG) performance status grade 0 – 2
- •6.Life expectancy of greater than 6 months
- •7.Written informed consent
- •8.Willing to comply with the contraceptive requirements of the trial
- •9.Negative serum or urine pregnancy test for women of childbearing potential (WOCBP)
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •1. Prior therapy for WM
- •2. Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein
- •3. CNS involvement with WM
- •4. Autoimmune cytopenias
- •5. Major surgery within 4 weeks prior to randomisation
- •6. Clinically significant cardiac disease including the following:
- •o Myocardial infarction within 6 months prior to randomisation
- •o Unstable angina within 3 months prior to randomisation
- •o New York Heart Association class III or IV congestive heart failure
- •o History of clinically significant arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- •o QTcF > 480 msecs based on Fredericia’s formula
- •o History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
- •o Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mm Hg
- •o Cardiac event within 6 months of screening (e.g. coronary artery stent) requiring dual antiplatelet treatment
- •7. History of stroke or intracranial haemorrhage within 6 months prior to randomisation
- •8. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (direct oral anticoagulants (DOACs) allowed)
- •9. History of severe bleeding disorders considered not to be disease related (Haemophilia A, B or von Willebrand’s disease)
- •10. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
- •11. Known infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:
- •o Presence of hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the patient will be excluded
- •o Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable
- •12. Women who are pregnant or breastfeeding or males expecting to conceive or father children at any point from the start of treatment until the end of the at risk period
- •13. Renal failure (creatinine clearance <30 ml/min as estimated by the Cockroft-Gault equation)
- •14. Patients with chronic liver disease with hepatic impairment Child-Pugh class B or C
- •15. Known history of anaphylaxis to any of the IMPs or its excipients, in addition to murine derived monoclonal antibodies
- •16. Received live vaccine six weeks prior to first dose of study therapy
- •17. Inability to swallow oral medication
- •18. Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (e.g. malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease)
- •19. Active systemic infection requiring treatment
- •20. Concomitant treatment with another investigational agent
- •21. Any life-threatening illness, medical condition, organ system dysfunction, need for profound anticoagulation, or bleeding disorder, which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at risk
- •22. Unwilling or unable to take PJP prophylaxis (e.g. cotrimoxazole)
- •23. History of prior malignancy, with the exception of the following:
- •o Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician
- •o Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma, superficial bladder cancer, ca
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