临床试验/NCT00765245

NCT00765245已完成2 期

A Phase II Randomized Study of Lenalidomide or Lenalidomide and Rituximab as Maintenance Therapy Following Standard Chemotherapy for Patients With High/High-intermediate Risk Diffuse Large B-Cell Lymphoma

Vanderbilt-Ingram Cancer Center4 个研究点分布在 1 个国家目标入组 44 人开始时间: 2008年10月最近更新: 2016年4月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Vanderbilt-Ingram Cancer Center
入组人数: 44
试验地点: 4
主要终点: Disease-free Survival at 1 Year

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

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating diffuse large B-cell non-Hodgkin lymphoma.

PURPOSE: This randomized phase II trial is studying lenalidomide to see how well it works when given with or without rituximab after standard chemotherapy in treating patients with diffuse large B-cell non-Hodgkin lymphoma.

详细描述

OBJECTIVES:

Primary

To assess the 1-year disease-free and relapse-free survival of patients with high- or high/intermediate-risk diffuse large B-cell non-Hodgkin lymphoma treated with maintenance therapy comprising lenalidomide with or without rituximab following standard chemotherapy.

Secondary

To assess the 2-year disease-free survival of patients treated with these regimens.
To define the safety and toxicity profile of these regimens.
To perform antibody-dependent cellular cytotoxicity assays using peripheral blood mononuclear cell samples from these patients.
To assess the change in the number of natural killer cells by flow cytometric analysis.
To evaluate cytokines including, but not limited to, sIL-2R, IL-6, IL-15, IL-12, TNF-α, and IFN-γ in these patients.
To study the KIR genotype receptor and FCγR polymorphisms.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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

•Understand and voluntarily sign an Informed Consent form
•Age > 18 years at time of signing the Informed Consent Form
•Able to adhere to the study visit schedule and other protocol requirements.
•Patients with histological confirmation of diffuse large B cell lymphoma with at least one of the following characteristics:
•High or intermediate IPI score (See Appendix 8.0 for IPI scoring criteria)
•Patients who are still PET scan positive mid therapy with R-CHOP, but, have turned negative after completion of therapy.
•Low risk International prognostic index ie., an IPI score of <3 if age >60 years or <2 if age is less than or equal to 60 with c-myc positive by Fluorescent In situ Hybridization.
•No other previous lymphoma therapy, hormonal therapy or surgery, except for standard therapy with R-CHOP with or without radiation and with or without prophylactic Methotrexate therapy. Patients must be enrolled within 4-12 weeks of completion of therapy.
•At the time of study entry following standard therapy with R-CHOP±RT, patients should be in complete remission.
•ECOG performance status of ≤ 2 at study entry
•Laboratory test results within these ranges:
•Absolute neutrophil count ≥ 1500/mm³
•Platelet count ≥100K /mm³
•Serum creatinine ≤ 2.0 mg/dL
•Total bilirubin ≤ 1.5 mg/dL
•AST (SGOT) and ALT (SGPT) ≤ 2 x ULN
•Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
•All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the Revlimid REMS® program.
•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 and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by the Revlimid REMS® program) 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.
•Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation, if patients are thought to be at an elevated risk of thrombosis.

排除标准

•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the Informed Consent
•Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Known hypersensitivity to thalidomide.
•The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
•Any prior use of lenalidomide.
•Concurrent use of other anti-cancer agents or treatments.
•Known positive for HIV or infectious hepatitis, type B or C.
•A diagnosis of deep vein thromboses in the preceding 3 months of study enrollment.

研究组 & 干预措施

Arm II: Lenalidomide and Rituximab IV

Experimental

Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

干预措施: Rituximab (Drug)

Arm II: Lenalidomide and Rituximab IV

Experimental

Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

干预措施: Lenalidomide (Drug)

Arm I: Lenalidomide

Experimental

干预措施: Lenalidomide (Drug)

结局指标

主要结局

Disease-free Survival at 1 Year

时间窗: From on-treatment date to disease recurrence, up to 1 year

Disease-free survival is the time from on-treatment to first relapse or death (whichever comes first). Those who are alive and without relapse are censored at the last date known alive.

次要结局

Number of Patients With Each Worst-Grade Toxicity(30 days after completing treatment, for up to 13 months)
Disease-free Survival at 2 Years(From on-treatment date to disease recurrence, up to 2 years)

研究者

发起方

Vanderbilt-Ingram Cancer Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Nishitha Reddy, MD

Assistant Professor of Medicine; Hematologist/Oncologist

Vanderbilt-Ingram Cancer Center

研究点 (4)

Loading locations...

相似试验

终止

1 期

Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal CancerFallopian Tube CancerPeritoneal Cavity CancerOvarian Cancer

NCT00903630Masonic Cancer Center, University of Minnesota15

已完成

2 期

Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin LymphomaLymphoma

NCT00784927Mayo Clinic36

已完成

1 期

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic SyndromesMyelodysplastic SyndromesLeukemia

NCT00352001Mikkael Sekeres MD37

终止

1 期

NCT01045928Case Comprehensive Cancer Center5

终止

1 期

Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal CancerRectal CancerColon Cancer

NCT01126450Case Comprehensive Cancer Center3