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.
調査の概要
研究の種類
観察的
入学 (実際)
260
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Neuilly-sur-seine、フランス、92521
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants With Last Induction Treatment Response
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年2月1日
一次修了 (実際)
2013年4月1日
研究の完了 (実際)
2013年4月1日
試験登録日
最初に提出
2014年11月28日
QC基準を満たした最初の提出物
2014年12月10日
最初の投稿 (見積もり)
2014年12月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年2月25日
QC基準を満たした最後の更新が送信されました
2016年1月28日
最終確認日
2016年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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