OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 主要终点
- Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Rituximab (Drug)
结局指标
主要结局
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
时间窗: Induction Phase: 18.7 months
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.
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
时间窗: Induction Phase: 18.7 months
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.
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
时间窗: Baseline
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.
Percentage of Participants With MabThera as Maintenance Therapy
时间窗: Maintenance/observation Phase: 67.8 months
During the maintenance period participants received four weekly infusion of MabThera.
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
时间窗: Maintenance/observation Phase: 67.8 months
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.
Duration of MabThera Maintenance Therapy When Associated With Observation
时间窗: Maintenance/observation Phase: 67.8 months
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.
Percentage of Participants With Prescription of Injection Prophylaxis
时间窗: Maintenance/observation Phase: 67.8 months
Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.
Percentage of Participants With Injection Prophylaxis Treatment
时间窗: Maintenance/observation Phase: 67.8 months
Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
时间窗: Up to 6 years
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.
Number of Participants With Therapeutic Management After the First Study Disease Progression
时间窗: Up to 6 years
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.
次要结局
- Percentage of Participants With Last Induction Treatment Response(Induction Phase: 18.7 months)
- Percentage of Participants With Number of Disease Progressions(Up to 6 years)
- Percentage of Participants With Disease Characteristics at First Study Disease Progression(Up to 6 years)
- Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase(Maintenance phase : 67.8 months)
- Progression Free Survival (PFS)(Up to 6 years)
- Time to Next Treatment(Up to 6 years)
- Overall Survival (OS)(Up to 6 years)
- Number of Participants Who Used MabThera(Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months))
- MabThera Regimen: Dose of MabThera(Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months))
- MabThera Regimen: Infusion Duration(Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months))
- MabThera Regimen: Number of Cycles of MabThera(Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months))
- MabThera Regimen: Time Between Cycles(Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months))
- Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score(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]))
- Number and Type of Hospitalization Associated With MabThera Perfusion(Up to 6 years)