BREVITY: A phase II study of brentuximab vedotin using a response adapted design in patients with Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty or co-morbidity - BREVITY: Brentuximab vedotin in patients with Hodgkin lymphoma

niversity of Birmingham0 个研究点目标入组 38 人开始时间: 2013年6月7日最近更新: 2019年2月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: niversity of Birmingham
入组人数: 38

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Histologically confirmed CD30 positive classical Hodgkin lymphoma
•2. No previous treatment for classical Hodgkin lymphoma
•3. Aged more than or equal to 16 years
•4. Stages II (with B symptoms, extranodal disease, bulky disease, =3 sites of nodal involvement, fewer than 3 sites of nodal involvement but unsuitable for radiotherapy because of anatomical distribution or ESR =50 mm/h), III and IV classical Hodgkin lymphoma
•5. Any of the following:
•At any age, standard chemotherapy considered inappropriate because:
•a. Impaired cardiac function defined either by an ejection fraction of less than 50% assessed by echocardiogram or nuclear medicine scan (MUGA)
•b. Left ventricular ejection fraction =50% measured by MUGA or echocardiography but in the presence of significant co-morbidities or cardiac risk factors such as diabetes mellitus, hypertension, peripheral vascular disease, ischaemic heart disease, previous myocardial infarction, obesity, stroke or transient ischaemic attacks (TIA) that make anthracycline-containing chemotherapy inadvisable as determined by the treating physician.
•c.Heart failure clinically determined by the presence of New York Heart Association (NYHA) heart failure grade II and III due to a cause other than HL
•d.Impaired respiratory function with DLCO and/or FVC/FEV1 ratio less than 75% of predicted due to a cause other than HL
•For patients aged 60 years or older,
•e. an ECOG score of 1, 2 or 3 for any reason, before the start of permitted steroids and considered unsuitable for treatment with standard chemotherapy by the supervising physician.
•6.FDG avid disease
•7.Measurable disease with at least one lesion measuring 1.5 cm in short axis diameter
•8.Written informed consent
•9.Able to comply with requirements of the protocol (including PET scans)
•10.Agree and be able to use adequate contraception if required
•Are the trial subjects under 18? yes
•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 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

排除标准

•1. Nodular lymphocyte predominant Hodgkin lymphoma
•2. Grade 2 or worse peripheral neuropathy
•3. Haemoglobin <9 g/dl (transfusion allowed)
•4. Unsupported neutrophil count <1.0 x 10-9/l and platelet count <100 x 10-9/l unless due to bone marrow infiltration by Hodgkin lymphoma demonstrated by trephine biopsy
•5. Serum bilirubin more than 1.5 times upper limit normal unless due to Hodgkin lymphoma or Gilbert’s syndrome
•6. Creatinine clearance < 30 ml/min (calculated by the modified Cockroft-Gault formula, see appendix) unless due to Hodgkin lymphoma. Patients with an eGFR < 30 ml/min but a measured GFR by other method (e.g. EDTA) of 30ml/min or greater would be eligible.
•7. Pregnant or lactating women
•8. Concurrent metastatic or new diagnosis of malignancy within the last 24 months – except appropriately treated superficial melanoma, basal cell carcinoma and squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia or in situ or organ confined prostate cancer not currently requiring therapy
•9. The use of other investigational or anti-neoplastic agents within the previous 6 weeks or during the trial. Corticosteroids are allowable for immediate relief of symptoms
•10. Known to be HIV, Hep B positive (Hep B Core antibody positive allows inclusion providing surface / core antigen both negative) or Hep C positive (Hep C antibody positive allows inclusion providing PCR for viral RNA is negative).
•11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
•12. Known cerebral or meningeal involvement by Hodgkin Lymphoma
•13. Symptoms or signs of PML
•14. Any active systemic viral, bacterial, or fungal infection requiring intravenous antibiotics within 2 weeks prior to cycle 1 day 1 of brentuximab vedotin
•15. Evidence of current uncontrolled cardiovascular conditions, including unstable angina and NYHA grade IV

研究者

发起方

niversity of Birmingham

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