临床试验/NCT01241786

NCT01241786终止2 期

A Phase II, Single Arm Study Examining the Combination of Revlimid (Lenalidomide) and Vidaza (Azacitidine) (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

Hackensack Meridian Health1 个研究点分布在 1 个国家目标入组 5 人开始时间: 2010年7月最近更新: 2022年7月20日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Hackensack Meridian Health
入组人数: 5
试验地点: 1
主要终点: the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the response to the combination of Revlimid (Lenalidomide)+ Vidaza (Azacitidine) in patients with relapsed/refractory CLL and SLL

Hypothesis- lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.

详细描述

Treatment response of lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.

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

•Patients must be age ≥ 18 must have an ECOG PS ≤ 2 must understand and voluntarily sign informed consent adhere to the study protocol requirements and schedule must carry the diagnosis of B-CLL/SLL, SLL/CLL must be defined as relapsed or refractory disease Pts. must have received and failed at least one purine-based treatment regimen (ie. FCR, FR, PCR, Fludarabine) or alemtuzumab-based regimen or bendamustine-based regimen prior to study enrollment Serum bilirubin levels <1.5 times the upper limit of the normal range for the laboratory (ULN) Higher levels are acceptable if these can be attributed to active hemolysis, ineffective erythropoiesis or Gilbert's disease.Serum (SGOT) [AST])(SGPT) [ALT]) levels <2 x ULN or <5 x ULN if hepatic metastases are present) Subjects must have calculated creatinine clearance ≥ 30ml/min Absolute neutrophil count > 1.0 x 109 / L Platelet count > 50x 109 / L (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast All participants must be registered into the mandatory RevAssist® program Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.

排除标准

•Patient must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would places the subject at unacceptable risk or confound the interpretation of data from the study Patients must be lenalidomide / azacitidine naïve prior to study enrollment Patients must not be HIV, Hepatitis B or Hepatitis C positive, except for Patients who are seropositive because of hepatitis B virus vaccine are eligible Patients must not have received chemotherapy, immunotherapy or any experimental study drug for CLL or SLL at least 4 weeks prior to study enrollment and initiation of treatment Patients with history of B-CLL and the development of prolymphocytic leukemia or Richter's transformation Known or suspected hypersensitivity to azacitidine, mannitol, thalidomide or Lenalidomide Pregnant or breast feeding females are not eligible or lactating females must agree not to breast feed while taking Lenalidomide Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome Subjects may be enrolled upon correction of electrolyte abnormalities Patients with advanced malignant hepatic tumors; Concurrent use of other anti-cancer agents or treatments, or Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.

研究组 & 干预措施

response to Vidaza + Revlimid

Experimental

response to combination of azacitidine + lenalidomide A Phase II, Single Arm Study Examining the Combination of Revlimid (Lenalidomide) and Vidaza (Azacitidine) (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)

干预措施: Revlimid (Drug)

response to Vidaza + Revlimid

Experimental

干预措施: Azacitidine (Drug)

结局指标

主要结局

the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients

时间窗: 9 Months

the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).

次要结局

The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine(9 Months)
The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine(9 Months)
Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine.(30 days after treatment completion (up to 10 Months))

研究者

发起方

Hackensack Meridian Health

申办方类型

Other

责任方

Sponsor

研究点 (1)

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