EUCTR2009-010017-72-FR进行中（未招募）不适用
Bendamustine in patients with refractory or relapsed T-cell lymphoma. A phase II multicenter studyBENTLY” - BENTLY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GOELAMS
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients aged more than 18 years
- •Must have measurable disease on cross sectional imaging by CT that is at least 2 cm in the longest diameter and measurable in two perpendicular dimensions
- •Refractory or relapsed peripheral T-cell NHL (PTCL).
- •oPeripheral T-cell lymphoma unspecified.
- •oAngioimmunoblastic lymphadenopathy disease.
- •oAnaplastic T-cell lymphoma (ALK positive or negative).
- •oNK/T cell lymphoma.
- •oSubcutaneous panniculitis T-cell lymphoma.
- •oHepatosplenic T-cell lymphoma.
- •oEnteropathy associated T-cell lymphoma.
- •Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy.
- •oMycosis fungoides more or equal to IIB (appendices 9)
- •Life expectancy > 3 months.
- •ECOG score ? 2.
- •No major organ dysfunction unrelated to lymphoma. Creatinine clearance > 10 ml/min.
- •Platelet count > 100x109/L; ANC > 1x109/L.
- •Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed.
- •Patient should be able and willing to comply with study visits and procedures per protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breast feeding women.
- •ECOG score > 2.
- •Estimate survival time < 3 months.
- •Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy.
- •Creatinine clearance < 10 ml/min or severe hepatic dysfunction not related to lymphoma.
- •Platelet count <100x109/L; ANC < 1x109/L and not secondary to lymphoma.
- •Patients who receive other concurrent investigational agent.
- •Previous chemotherapy/immunotherapy within 3 weeks before study entry or failure to recover from associated adverse events.
- •Investigational treatment within 28 days before inclusion
- •° Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •° Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- •Prior history of malignancies, other than T cell lymphoma, unless the patient has been free of the disease for = 3 years. Exceptions include the following:
- •- Basal cell carcinoma of the skin
- •- Squamous cell carcinoma of the skin
- •- Carcinoma in situ of the cervix
- •- Carcinoma in situ of the breast
- •- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- •° Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •CNS lymphoma
- •T-cell Leukemia lymphoma associated with HTLV1.
- •Sezary syndrome.
研究者
相似试验
招募中
2 期
Clinical trials for HDC / ASCT indication rrDLBCRelapsed or recurrent diffuse large B-cell lymphomaJPRN-jRCTs071210121Terui Yasuhito20
进行中（未招募）
1 期
Bendamustine and Rituximab for the treatment of Splenic Marginal Zone Lymphoma. The IELSG-36 phase II prospective study.Splenic Marginal Zone LymphomaMedDRA version: 14.1Level: PTClassification code 10062113Term: Splenic marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-000880-28-ITINTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP (IELSG)78
进行中（未招募）
1 期
A phase II study with bendamustine plus brentuximab vedotin in Hodgkin’s lymphoma and CD30+ peripheral T-cell lymphoma in first salvage setting: the BBV regimen.Hodgkin’s lymphoma and CD30+ peripheral T-cell lymphomaMedDRA version: 22.0Level: LLTClassification code 10012877Term: Diffuse large cell lymphoma (Peripheral T-cell lymphoma unspecified) (Working Formulation) recurrentSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864EUCTR2014-005382-79-ITFONDAZIONE ITALIANA LINFOMI ONLUS65
已完成
2 期
Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapyuntreated and advanced follicular lymphomaJPRN-UMIN000013795Department of Hematology and Rheumatology,Kinki University Faculty of Medicine60
进行中（未招募）
不适用
A Phase II study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent non-follicular Non-Hodgkin’s LymphomaPatients with advanced untreated Indolent non Follicular non-Hodgkin LymphomasMedDRA version: 14.1Level: PTClassification code 10065856Term: Non-Hodgkin's lymphoma unspecified histology indolentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-019248-37-ITFONDAZIONE ITALIANA LINFOMI ONLUS