NCT01142011Unknown2 期
A Single Arm, Phase II Study of the Anti-Blys Monoclonal Antibody, Belimumab in Symptomatic Waldenstroms Macroglobulinaemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of Belimumab infusions in symptomatic WM
研究概览
简要总结
Hypothesis; That inhibition of plasma Blys by the monoclonal antibody Belimumab will reduce both the survival of the lymphoplasmacytoid cells of Waldenstrom Macroglobulinaemia (WM), and their production of monoclonal IgM, resulting in a reduction of IgM paraprotein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Diagnosis of WM histologically confirmed on bone marrow biopsy.
- •Detectable IgM paraprotein >5 g/L
- •Less than 3 lines of prior therapy for WM
- •Full blood count within 4 weeks prior to screening shows ANC >1.0 x109/l AND platelet count >50 x109/l
- •Therapy indicated due to development of one or more of the following:
- •symptomatic anaemia
- •hyperviscosity symptoms
- •rapidly rising paraprotein of >25% or >5g/l over 3 months
- •splenomegaly
- •bulky lymphadenopathy
- •B symptoms or paraneoplastic phenomena, which, in the opinion of the investigator are the result of progressive WM.
- •Life expectancy >12 months
- •ECOG < 3
- •Able to provide informed consent
- •Ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the protocol procedures, including required study visits.
- •Subjects of child bearing potential must agree to use effective contraception throughout the study and for 3 months after the last dose of belimumab
排除标准
- •Prior therapy with belimumab.
- •Pregnant or breast feeding
- •Chemotherapy, immunotherapy or biological therapy within 4 weeks of enrolment. Therapeutic plasma exchange can continue- see section 3.1.
- •Creatinine clearance (calculated by Cockcroft-Gault) < 60ml/min
- •Bilirubin >2x ULN, ALT >2x ULN.
- •History of an allergic or anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies, a history of severe allergic reaction to drugs, food, or insects requiring medical intervention, or a history of hypersensitive triad (having all 3 features of allergic rhinitis with nasal polyps, asthma, and aspirin sensitivity).
- •Prior opportunistic infection including tuberculosis or atypical mycobacterial infection, multi-dermatome Herpes Zoster or Pneumocystis pneumonia or invasive fungal infection (not including oral or vaginal candidiasis or superficial dermatophytes) .
- •Active infection with hepatitis B, hepatitis C or HIV or historically positive test or test positive at screening for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody.
- •History of organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
- •Planned surgical procedure during the treatment period of this study or a history of any other medical disease (eg, cardiopulmonary), laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
- •Hospitalization for treatment of infection within 60 days of Day
- •Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day
- •Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 1.
研究组 & 干预措施
Belimumab
Experimental
The first cycle of Belimumab is a loading cycle of 3 doses over 28 days (days 1, 15, 29).
After the first cycle, additional cycles of belimumab will be administered every 28 ± 1 days (cycle 2 and all subsequent cycles).
干预措施: Belimumab (Drug)
结局指标
主要结局
Safety of Belimumab infusions in symptomatic WM
时间窗: Patients are assessed every 28 days while on treatment
次要结局
- Reduction of IgM paraprotein(Serum Immunoglobulins will be tested every 28 days)
- Reduction of splenomegaly and/or lymphadenopathy(This will be tested every 28 days)
- Improvement in anaemia(Patients will be assessed every 28 days while on treatment)
- Correlate the degree of response with Belimumab levels(Pharmacokinetics will be performed on days 1, 15, 56, 168, 364)
研究者
研究点 (2)
Loading locations...
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