Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)
2016年1月28日 更新者：Hoffmann-La Roche
OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma
This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy.
Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.
研究概览
研究类型
观察性的
注册 (实际的)
260
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
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Neuilly-sur-seine、法国、92521
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Recruitment of approximately 90 physicians who treat patients with follicular non-Hodgkin's lymphoma to actively participate in this observational study.
Patients with relapsed or refractory follicular non-Hodgkin's lymphoma (World Health Organization grade 1-3) and requiring treatment are to be enrolled prospectively.
Subgroup of interest: patients receiving MabThera® (rituximab) maintenance therapy.
描述
Inclusion Criteria:
- Adult patient (age >/= 18 years)
- Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis
- In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy
- Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data
Exclusion Criteria:
- Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion
- Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma
- First line treatment with radiotherapy alone
- Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)
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
队列和干预
团体/队列 |
干预/治疗 |
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All Participants
Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
All participants received at least one cycle of rituximab (MabThera) during maintenance therapy or observation period.
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其他名称：
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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 |
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Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
大体时间：Baseline
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At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician."
Percentage of participants with each of these modalities of therapeutic decision was reported.
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Baseline
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Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
大体时间：Induction Phase: 18.7 months
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Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment.
Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response).
Induction treatment duration ranged between <3 months to >6 months.
Each participants may received more than one therapy.
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Induction Phase: 18.7 months
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Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
大体时间：Induction Phase: 18.7 months
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Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy.
One participant could receive more than one type of chemotherapy over the first treatment induction period.
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Induction Phase: 18.7 months
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Percentage of Participants With MabThera as Maintenance Therapy
大体时间：Maintenance/observation Phase: 67.8 months
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During the maintenance period participants received four weekly infusion of MabThera.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
大体时间：Maintenance/observation Phase: 67.8 months
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After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.
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Maintenance/observation Phase: 67.8 months
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Duration of MabThera Maintenance Therapy When Associated With Observation
大体时间：Maintenance/observation Phase: 67.8 months
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Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up).
Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With Prescription of Injection Prophylaxis
大体时间：Maintenance/observation Phase: 67.8 months
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Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With Injection Prophylaxis Treatment
大体时间：Maintenance/observation Phase: 67.8 months
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Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis.
One participant could receive more than one infection prophylaxis treatment.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
大体时间：Up to 6 years
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The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician."
Percentage of participants with each of these modalities of therapeutic decision was reported.
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Up to 6 years
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Number of Participants With Therapeutic Management After the First Study Disease Progression
大体时间：Up to 6 years
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After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma.
One participant could receive more than one type of treatment after the first study disease progression.
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Up to 6 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Last Induction Treatment Response
大体时间：Induction Phase: 18.7 months
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Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.
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Induction Phase: 18.7 months
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Percentage of Participants With Number of Disease Progressions
大体时间：Up to 6 years
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Participants with at least one disease progression after the first study induction period were reported.
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Up to 6 years
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Percentage of Participants With Disease Characteristics at First Study Disease Progression
大体时间：Up to 6 years
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Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan.
Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L.
One participant could present with more than 1 GELF criterion.
Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).
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Up to 6 years
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Progression Free Survival (PFS)
大体时间：Up to 6 years
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The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.
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Up to 6 years
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Time to Next Treatment
大体时间：Up to 6 years
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Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.
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Up to 6 years
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Overall Survival (OS)
大体时间：Up to 6 years
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The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal.
OS was calculated using Kaplan-Meier method.
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Up to 6 years
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Number of Participants Who Used MabThera
大体时间：Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Dose of MabThera
大体时间：Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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All participants who received MabThera treatment before the first disease progression were reported.
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Infusion Duration
大体时间：Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Number of Cycles of MabThera
大体时间：Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Time Between Cycles
大体时间：Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase
大体时间：Maintenance phase : 67.8 months
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Maintenance phase : 67.8 months
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Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score
大体时间：Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])
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The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much").
Total score ranges from 0 to 168.
Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items.
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Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])
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Number and Type of Hospitalization Associated With MabThera Perfusion
大体时间：Up to 6 years
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Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.
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Up to 6 years
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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。
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
2007年2月1日
初级完成 (实际的)
2013年4月1日
研究完成 (实际的)
2013年4月1日
研究注册日期
首次提交
2014年11月28日
首先提交符合 QC 标准的
2014年12月10日
首次发布 (估计)
2014年12月15日
研究记录更新
最后更新发布 (估计)
2016年2月25日
上次提交的符合 QC 标准的更新
2016年1月28日
最后验证
2016年1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.
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