ISRCTN51382468已完成2 期
Combination fludarabine and cyclophosphamide (FC) plus Ofatumumab at Standard or Mega dose In Chronic lymphoid leukemia (CLL): a phase II, multi-centre, randomised, open, parallel group trial
eeds Teaching Hospitals NHS Trust (UK)0 个研究点目标入组 62 人开始时间: 2011年9月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27645620 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34028800/ (added 04/06/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. At least 18 years old
- •2. Chronic lymphocytic leukaemia requiring therapy
- •3. Previous treatment with at least one chemotherapeutic regime
- •4. Be capable of giving written informed consent
- •5. World Health Organisation (WHO) performance status (PS) of 0, 1, or 2
- •6. Life expectancy of at least 12 weeks
- •7. Considered fit enough to receive fludarabine-based combinations
排除标准
- •1. Fludarabine refractory: defined as no response to or relapse within 6 months of fludarabine alone or in combination with cyclophosphamide (FC)
- •2. Relapse within 12 months of FC with rituximab (FCR)
- •3. Deletion of chromosome 17p on fluorescent in-situ hybridisation (FISH) [will be performed in Haematological Malignancy Diagnostic Service (HMDS) at screening]
- •4. Previous treatment with ofatumumab either alone or in combination with chemotherapy
- •5. Toxicity attributable to purine analogues such as autoimmune haemolytic anaemia,
- •neurological toxicity or allergy
- •6. Active infection
- •7. Other severe, concurrent (particularly cardiac or pulmonary) diseases or mental disorders that could interfere with their ability to participate in the study
- •8. Patients with a creatinine clearance of less than 30ml/min (either measured or derived by the Cockcroft-Gault formula)
- •9. Pregnant, lactating or women of child bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished
- •10. Men whose partners are capable of having children but who are not willing to use
- •appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished, unless they are surgically sterile
- •11. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per Investigator assessment)
- •12. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment, whichever is longer, or currently participating in any other interventional clinical study
- •13. Other past or current malignancy. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •14. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
- •15. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C
- •16. History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- •17. Known human immunodeficiency (HIV) positive
- •18. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomisation, congestive heart failure New York Heart Association (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- •19. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the Investigator may represent a risk for the patient.
- •20. Positive serology for Hepatitis B (HB) defined as a positive test for 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 subject will be excluded
- •21. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to conf
研究者
相似试验
已完成
不适用
Fludarabine versus Fludarabine plus Cyclophosphamide in first line therapy of younger patients (up to 65 years) with advanced Chronic Lymphocytic LeukemiaChronic lymphocytic leukemia (CLL), advanced stageChronic lymphocytic leukemiaCancerISRCTN75653261German CLL Study Group (GCLLSG)375
已完成
1 期
Cyclophosphamide and Fludarabine to Treat Lupus NephritisSystemic Lupus ErythematosusGlomerulonephritisLupus NephritisNCT00001676National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)15
进行中（未招募）
1 期
Phase ll Trial of Fludarabine & Cyclophosphamide followed by Thalidomide for Angioimmunoblastic Lymphoma - AITEUCTR2005-003931-40-GBniversity College London15
已完成
2 期
Fludarabine, Cyclophosphamide, and Rituximab - High Dose FrontlineChronic Lymphocytic LeukemiaNCT00794820M.D. Anderson Cancer Center66
已完成
2 期
Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic LeukemiaNCT01082939M.D. Anderson Cancer Center80