Pralatrexate for Relapsed or Refractory Peripheral T-cell Lymphoma: a Multicenter, Multinational Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Overall response rate (ORR) including complete remission (CR) and partial remission (PR)
研究概览
简要总结
A non-interventional, multicenter, multinational retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
详细描述
All patients who satisfy the inclusion criteria for this study in each participating institution will be included. Considering the number of participating centers in Korea, Latin America (Mexico, Colombia), and Europe (Switzerland, Israel), the expected number of patients is 50.
This research involves only the collection and analysis of existing data, documents, and records. The information will be recorded by the investigators on a CRF in a way that the subjects cannot be identified directly or through identifiers linked to the subjects. Thus, this study should be reviewed and approved by the Institutional Review Board of each participating institute, and exemption from additional written informed consent should be applied.
- Age, sex, nationality, ethnicity
- Ann Arbor stage, disease involved sites, number of extranodal involvement, serum LDH concentration, ECOG performance status, presence of B symptoms, regional lymph node involvement, International Prognostic Index, bone marrow invasion at the time of pralatrexate treatment
- Dose and schedule of pralatrexate, start date, last treatment date, other treatment modalities
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Histologically confirmed peripheral T-cell lymphoma according to following inclusion criteria of subtypes according to the 2016 revision of the World Health Organization classification of lymphoid neoplasm
- •Adult T-cell leukemia/lymphoma
- •Angioimmunoblastic T-cell lymphoma
- •Anaplastic large cell lymphoma, ALK positive
- •Anaplastic large cell lymphoma, ALK negative
- •Peripheral T-cell lymphoma, NOS
- •Enteropathy-type intestinal lymphoma
- •Hepatosplenic T-cell lymphoma
- •Extranodal NK/T-cell lymphoma, nasal type
- •Subcutaneous panniculitis-like T-cell lymphoma
- •Transformed mycosis fungoides
- •Mycosis fungoides
- •Sézary syndrome
- •Primary cutaneous CD30+T-cell lymphoproliferative disorder (primary cutaneous anaplastic large cell lymphoma)
- •Primary cutaneous gamma-delta T-cell lymphoma
- •Age ≥ 18 years old
- •Patients treated with pralatrexate due to relapse or refractory disease after primary and/or salvage treatment. Relapse following an autologous stem cell transplant allowed.
- •Patients treated with pralatrexate 30mg/m2 once a week for 6 weeks as part of a 7-week cycle. However, modified dose and/or schedule allowed.
排除标准
- •Histologically confirmed peripheral T-cell lymphoma with following exclusion criteria of subtypes
- •Aggressive NK-cell leukemia
- •T-cell prolymphocytic leukemia
- •T-cell large granular lymphocytic leukemia
- •Primary cutaneous CD30+ T-cell lymphoproliferative disorders (lymphomatoid papulosis)
- •Patients with active/symptomatic central nervous system (CNS) involvement.
- •HIV-related lymphoma
- •Prior allogeneic stem cell transplant within 6 months.
- •Concurrent active or history of other malignancies.
- •Concurrent uncontrolled serious medical or psychiatric conditions
结局指标
主要结局
Overall response rate (ORR) including complete remission (CR) and partial remission (PR)
时间窗: This is a restrospective study. Data collection and analysis will be done for 6 months.
retrospective analysis using electronic case report forms completed by the investigators based on information from patient medical records
次要结局
- Progression-free survival (PFS)(This is a restrospective study. Data collection and analysis will be done for 6 months.)
- Overall survival (OS)(This is a restrospective study. Data collection and analysis will be done for 6 months.)
- Duration of response (DoR)(This is a restrospective study. Data collection and analysis will be done for 6 months.)
- Toxicity(This is a restrospective study. Data collection and analysis will be done for 6 months.)
- Tolerability(This is a restrospective study. Data collection and analysis will be done for 6 months.)
研究者
Won Seog Kim
MD
Samsung Medical Center