Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia. (CLL0911)
2020年10月12日 更新者：Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase 2 Multicenter, Study to Assess the Efficacy and the Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) Chemoimmunotherapy in Young (≤65 Yrs) Patients With Chronic Lymphocytic Leukemia (CLL).
Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia (CLL).
研究概览
详细说明
Given that:
- rituximab, fludarabine and cyclophosphamide (FCR) front-line treatment was associated with a high OR rate, superior PFS and OS as compared to fludarabine and cyclophosphamide regimen;
- a direct relationship between the dose of rituximab and the response rate has been reported;
- ofatumumab, as single agent, proved activity in CLL patients with refractory disease;
- ofatumumab, fludarabine and cylophosphamide (O-FC) front-line treatment has been associated with a high complete response (CR) rate;
- the expected grade 3-4 granulocytopenia could led to reduce the dose intensity of study drugs (FC) and increase the infection rate; a schedule combining FC with an increased dose of ofatumumab associated to primary phrophylaxis of granulocytopenia could be associated with an improvement in the CR rate. The purpose of this study is to determine whether we could improve the CR rate of the golden standard treatment for fit patients with CLL , the FCR regimen, with a chemoimmunotherapy including FC combined with an increased dose of the monoclonal antibody ofatumumab, given every other week (FCO2) associated with a primary prophylaxis of granulocytopenia.
研究类型
介入性
注册 (实际的)
80
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Alessandria、意大利
- S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
-
Ascoli Piceno、意大利
- Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
-
Asti、意大利
- S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
-
Biella、意大利
- ASL12 - Biella Ospedale degli Infermi - Dip. di Medicina e Geriatria - Struttura Complessa di Medicina Interna
-
Catanzaro、意大利
- Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
-
Ferrara、意大利
- Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
-
Genova、意大利
- RCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
-
Lecce、意大利
- ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
-
Messina、意大利
- Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
-
Milano、意大利
- Ospedale Niguarda " Ca Granda"
-
Novara、意大利
- S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
-
Palermo、意大利
- Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
-
Parma、意大利
- Cattedra di Ematologia CTMO Università degli Studi di Parma
-
Reggio Calabria、意大利
- Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
-
Reggio Emilia、意大利
- Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
-
Roma、意大利
- U.O.C. Ematologia - Ospedale S.Eugenio
-
Roma、意大利
- Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
-
Roma、意大利
- Policlinico Umberto I, Hematology Department - Sapienza
-
Siena、意大利
- U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
-
Terni、意大利
- SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni
-
Torino、意大利
- Div. di Ematologia Ospedale "S.Giovanni Battista"
-
Udine、意大利
- Clinica Ematologica - Policlinico Universitario
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- B-cell CLL diagnosis by 2008 revised IWCLL criteria.
- Treatment requirement according to the 2008 revised IWCLL criteria.
- No previous treatment.
- Age > 18 year and . 65 years.
- ECOG performance status of 0-1 at study entry and CIRS score .6.
- Adequate renal function (creatinine clearance.60 ml/min estimated using the Cockcroft-Gaultequation) .
- For male and female subjects of childbearing potential, agreement to use effective contraception.
- Signed written informed const according to ICH/EU/GCP and national local laws.
Exclusion Criteria:
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease and/or laboratory abnormality which in the opinion of the investigator may represent a risk for the patient and/or that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Known positive serology for HIV.
- Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA.
- HCV-RNA positive.
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection, tuberculosis and active hepatitis.
- History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
- Known presence of alcohol and/or drug abuse.
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to the inclusion in the study, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy.. grade 2 neuropathy; history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
One or more laboratory abnormalities:
- Calculated creatinine clearance (Cockroft-Gault)<60mL/min.
- Absolute granulocyte count <1500/ƒÊL not disease related.
- Platelet count < 75000/ƒÊL not disease related.
- GOT, GPT, GT, alkaline phosphatase > 1,5 x upper limit of normal value unless due to disease involvement); serum bilirubin >1.5mg/dL, subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones)
- Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
- Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of complete responses.
大体时间：After 8 months from study entry.
|
The complete response (CR) rate after FCO2 front-line treatment.
|
After 8 months from study entry.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of overall responses.
大体时间：After 8 months from study entry.
|
Overall Response (OR) rate after FCO2 front-line treatment.
|
After 8 months from study entry.
|
|
Number of patients in progression-free survival.
大体时间：After 32 months from study entry.
|
Progression-free survival (PFS) calculated from the date of first treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first.
Patients still alive and known to be progression free will be censored at the moment of last follow-up.
|
After 32 months from study entry.
|
|
Number of patients needing a new CLL Treatment.
大体时间：After 32 months from study entry.
|
Time to a new CLL treatment (TTT) will be calculated from the date of last treatment dose until date of a new treatment received for CLL, where death occurred before the new treatment will be considered as competing risk.
Patients still alive without receiving a new treatment will be censored at the time of the last follow-up.
|
After 32 months from study entry.
|
|
Number of patients in overall survival
大体时间：After 32 months from study entry.
|
Overall survival (OS): defined as the time interval between the date of first treatment dose - induction phase- and the date of death for any cause; patients still alive will be censored at the moment of last follow-up.
|
After 32 months from study entry.
|
|
Number of toxic events.
大体时间：After 32 months from study entry.
|
Toxicity of treatment according the last NCI criteria.
|
After 32 months from study entry.
|
|
Outcome of patients according to clinical and biologica variables.
大体时间：After 32 months from study entry.
|
Outcome of patients (response, PFS OS) according to clinical and biologic variables (age; size of nodes, 2-microglobulin, lymphocyte count, stage, IgVH, p53, FISH, ZAP-70, CD38, FLCs).
|
After 32 months from study entry.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Roberto Foà, Pr.、Policlinico Umberto I, Hematology Department.
- 研究主任：Francesca R. Mauro、Policlinico Umberto I, Hematology Department.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年11月5日
初级完成 (实际的)
2015年11月1日
研究完成 (实际的)
2018年10月1日
研究注册日期
首次提交
2013年1月4日
首先提交符合 QC 标准的
2013年1月4日
首次发布 (估计)
2013年1月7日
研究记录更新
最后更新发布 (实际的)
2020年10月14日
上次提交的符合 QC 标准的更新
2020年10月12日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.