ESTUDIO FASE 3, MULTICÉNTRICO, ALEATORIZADO, ABIERTO Y DE GRUPOS PARALELOS PARA VALORAR LA EFICACIA Y SEGURIDAD DE LENALIDOMIDA (REVLIMID®) FRENTE A CLORAMBUCILO COMO TERAPIA DE PRIMERA LÍNEA EN PACIENTES ANCIANOS CON LEUCEMIA LINFOCÍTICA CRÓNICA DE CÉLULAS B NO TRATADOS PREVIAMENTE (ENSAYO ORIGIN) //A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS CHLORAMBUCIL AS FIRST-LINE THERAPY FOR PREVIOUSLY UNTREATED ELDERLY PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA(THE ORIGIN TRIAL) - THE ORIGIN TRIA

Celgene Corporation0 个研究点目标入组 428 人开始时间: 2009年5月6日最近更新: 2018年8月20日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Celgene Corporation
入组人数: 428

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

性别: All

入选标准

•1.Must understand and voluntarily sign an informed consent form.
•2.Age ? 65 years at the time of signing the informed consent form.
•3.Must be able to adhere to the study visit schedule and other protocol requirements.
•4.Must have a documented diagnosis of B-cell CLL [IWCLL guidelines for diagnosis and treatment of CLL ] meeting at least one of the following criteria:
•?Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
•?Massive (i.e. > 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
•?Massive nodes (i.e. > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
•?Progressive lymphocytosis with an increase of > 50% over a 2 month period, or lymphocyte doubling time (LDT) of less than 6 months
•?A minimum of any one of the following disease-related symptoms must be present:
•Unintentional weight loss ? 10% within the previous 6 months
•Significant fatigue (i.e., ECOG PS 2; cannot work or unable to perform usual activities)
•Fevers of greater than 100.5° F or 38.0° C for 2 or more weeks without other evidence of infection
•Night sweats for more than 1 month without evidence of infection
•5.Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of ?2.
•6.Females of childbearing potential (FCBP) must:
•?Have a negative medically supervised pregnancy test prior to starting of study therapy and agree to ongoing pregnancy testing during the course of the study and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
•?Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy.
•7.Male patients must:
•?Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
•?Agree not to donate semen during study drug therapy and for a period after end of study drug therapy.
•8.All patients must:
•?Have an understanding that the study drug could have a potential teratogenic risk.
•?Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
•?Agree not to share study drug with another person.
•?All patients must be counseled about pregnancy precautions and risks of fetal exposure: Education and Counseling Guidance Document.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•1.Prior treatment for B-cell CLL.
•2.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form.
•3.Active infections requiring systemic antibiotics.
•4.Systemic infection that has not resolved > 2 months prior to initiating study treatment in spite of adequate anti-infective therapy
•5.Pregnant or lactating females.
•6.Participation in any clinical study or having taken any investigational therapy within 28 days prior to initiating study therapy.
•7.Known presence of alcohol and/or drug abuse.
•8.Central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging. Patients who have signs or symptoms suggestive of leukemic meningitis or a history of leukemic meningitis must have a lumbar puncture procedure performed within two weeks prior to randomization.
•9.Prior history of malignancies, other than CLL, unless the patient has been free of the disease for ?3 years. Exceptions include the following:
•?Basal cell carcinoma of the skin
•?Squamous cell carcinoma of the skin
•?Carcinoma in situ of the cervix
•?Carcinoma in situ of the breast
•?Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
•10.History of renal failure requiring dialysis.
•11.Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
•12.Prior therapy with lenalidomide.
•13.Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (patients may be enrolled upon correction of electrolyte abnormalities).
•14.Any of the following laboratory abnormalities:
•?Calculated (method of Cockroft-Gault) creatinine clearance of <30 mL/min
•?Absolute neutrophil count (ANC) < 1,000/?L (1.0 X 109/L)
•?Platelet count < 50,000/?L (50 X 109/L)
•?Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 5 x upper limit of normal (ULN)
•?Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert?s syndrome.
•15.Uncontrolled hyperthyroidism or hypothyroidism
•16.Venous thromboembolism within one year
•17.? Grade 2 neuropathy
•18.Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
•19.Disease transformation [i.e. Richter?s Syndrome (lymphomas) or prolymphocytic leukemia]

研究者

发起方

Celgene Corporation

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