ACTRN12608000404325已完成2 期
An Australian, phase II , multicentre, randomised, dose intensification study investigating oral fludarabine, oral cyclophosphamide, and intravenous rituximab (poFCivR) tolerance in previously untreated elderly (=65years old) patients with chronic lymphocytic leukaemia. (CLL)
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 120 人开始时间: 2008年8月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
The diagnosis and treatment of CLL may have a great impact on the quality of life (QoL) due to a variety of reasons including disease-related symptoms, infection, effects of therapy and the emotional, socio-economic, and functional effects of living with an 'incurable' illness. The main aim of any treatment is to maximize QoL by inducing remission with minimal short- and long-term toxicity. Balancing disease and symptom control with QoL in elderly patients receiving CLL therapy regimens can be challenging. There is little published QoL data in elderly CLL patients receiving the FCR (fludarabine, cyclophosphamide, rituximab) immunochemotherapy regimen. Our prior study showed no significant difference in health related QoL for first-line therapy of CLL with monotherapy between chlorambucil, fludarabine and cladribine (Mulligan, SP et al. Leuk Lymphoma, 2014).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. B-CLL confirmed according to National Cancer Institute (NCI) Working Group Criteria.
- •2. Binet stage B or C, or progressive symptomatic stage A (see Protocol Appendix I).
- •3. Age = 65 years old.
- •4. Judged to be in need of systemic therapy (see Protocol Appendix II).
- •5. No previous treatment (chemotherapy, radiotherapy or immunotherapy) for CLL.
- •6. Alkaline phosphatase and transaminases = 2 x ULN.(Upper Limits of Normal)
- •7. Creatinine clearance = 50 ml/min (as calculated by (estimated Glomerular Filtration Rate) eGFR; eGFR also calculated by
- •Cockcroft and Gault formula for final analysis; see Protocol Appendix III).
- •8. Females of childbearing potential or fertile males must take contraceptive measures during
- •and at least 6 months after cessation of therapy.
- •9. (Eastern Cooperative Group) ECOG performance status 0-1.
- •10. Cumulative Illnes Rating Scale CIRS score < 6 (see Protocol Appendix IV).
- •11. Life expectancy > 6 months.
- •12. Patient’s written informed consent.
排除标准
- •1. Age < 65 years old.
- •2. Non-progressive or stable Binet stage A.
- •3. Clinically significant auto-immune cytopenia, Coombs-positive haemolytic anaemia (as
- •discerned by treating physician).
- •4. Active second malignancy currently requiring treatment (except for non-melanoma skin
- •cancer or cervical cancer in situ or tumour treated curatively by surgery > 5 years ago)
- •5. Concomitant disease requiring prolonged use of glucocorticoids (> 1 month).
- •6. Known hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or
- •any of the study drugs.
- •7. ECOG performance status 2-3.
- •8. Class III or IV cardiac disease defined by the NYHA.
- •9. Severe or debilitating pulmonary disease.
- •10. Severe or debilitating central nervous system disease or cerebral dysfunction.
- •11. Transformation to aggressive B-cell malignancy, e.g. diffuse large cell lymphoma, Richter’s
- •syndrome or prolymphocytic leukaemia.
- •12. Active bacterial, viral or fungal infection; patients who have known Human Immunodeficiency
- •Virus (HIV) infection or active hepatitis B virus (HBV) or hepatitis C virus
- •(HCV) infection.
- •13. Total bilirubin > 2 x ULN.
- •14. Creatinine clearance < 50 ml/min (as calculated by eGFR).
- •15. Any coexisting medical or psychological condition that would preclude participation in the
- •required study procedures.
- •16. Treatment with any other investigational agent, or participation in another clinical trial
- •within 30 days prior to entering this study.
- •17. Pregnancy and lactation.
研究者
相似试验
已完成
不适用
Patient Reported Outcomes in Chronic Myeloid LeukemiaChronic Myeloid LeukemiaNCT01252589Gruppo Italiano Malattie EMatologiche dell'Adulto480
已完成
不适用
Quality of Life Study for Adult Patients With Acute Lymphoblastic LeukemiaAcute Lymphoblastic LeukemiaNCT01148927University Health Network, Toronto29
已完成
不适用
A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate CancerProstate CancerNCT00777452Samsung Medical Center93
进行中（未招募）
不适用
A Study of Clinical Outcomes in Chronic Lymphocytic Leukemia (CLL) Patients Treated With Venetoclax in GreeceChronic Lymphocytic LeukemiaNCT04159779AbbVie180
进行中（未招募）
不适用
Understanding Quality of Life Among Patients With Cancer Receiving Palliative CareCancerNCT05331625Abramson Cancer Center at Penn Medicine208