EUCTR2008-004759-31-GB进行中（未招募）不适用
Purine-Alkylator Combination In Follicular lymphoma Immuno-Chemotherapy for Older patients: a phase III comparison of first-line R-CVP versus R-FC lite - PACIFICO
niversity of Liverpool (lead sponsor, the trial is co-sponsored)0 个研究点开始时间: 2009年4月16日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Main Criteria for Inclusion: • Histologically confirmed follicular lymphoma (grade 1,2, and 3a with material available for central review) • Ann Arbor stage II-IV • Aged 60 years or over, or aged less than 60 but anthracycline-based therapy contra- indicated • No prior systemic therapy (one episode of prior local radiotherapy is allowed) • At least one of the following criteria for initiation of treatment: • Rapid generalized disease progression in the preceding 3 months • Life threatening organ involvement • Renal or macroscopic liver infiltration • Bone lesions • Presence of systemic symptoms or pruritus • Haemoglobin < 10 g/dL or WBC < 3.0 × 109/L or platelet counts < 100 × 109/L due to marrow involvement • Adequate haematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow): • Haemoglobin = 8.0 g/dL • Absolute neutrophil count (ANC) = 1.5 x 109/L • Platelet count = 100 x 109/L • Written Informed Consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Overt transformation to diffuse large B-cell lymphoma • Grade 3b follicular lymphoma • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis) • WHO performance status 3 or 4 • Impaired renal function defined as estimated Glomerular filtration rate (eGFR) < 30 mL/min using the MDRD formula • Impaired hepatic function defined as serum bilirubin more than twice upper limit of normal (unless due to lymphoma or Gilbert's syndrome) • Life expectancy less than 12 months • Pre-existing neuropathy • Active auto-immune haemolytic anaemia • Serological evidence of infection with HIV, hepatitis B(positivity for surface antigen or core antibody)or hepatitis C • Allergy to murine proteins • Corticosteroid treatment during the last 4 weeks, unless administered at a dose equivalent to no more than prednisolone 20 mg/day continuously or a single course of prednisolone 1mg/kg for up to 7 days • Concomitant malignancies except adequately treated localised non-melanoma skin cancer or in situ cervical cancer, or cancers that have been in remission for at least 5 years following surgery with curative intent • Major surgery (excluding lymph node biopsy) within 28 days prior to randomisation • Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease) • Treatment within a clinical trial within 30 days prior to trial entry • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent • Adult patient under tutelage (not competent to sign informed consent) • Pregnant or lactating women • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom
研究者
相似试验
已完成
3 期
Purine-Alkylator Combination In Follicular lymphoma Immuno-Chemotherapy for Older patientsFollicular [nodular] non-Hodgkin's lymphomaCancerFollicular lymphomaISRCTN99217456niversity of Liverpool (UK)680
尚未招募
不适用
Follicular Fluid Anti-Mullerian Hormone (AMH) levels and Assisted Reproductive Technology (ART) outcomes.CTRI/2019/05/019433il
已完成
不适用
Confirmation of lymphatic system with indocyanine greelung malignant tumorJPRN-UMIN000027878Kansai Medical University Medical Center200
招募中
不适用
Serum procalcitonin level in lymphoma patientslymphomalymphoma patients (pathological confirmation)serum procalcitoninserum procalcitoninTCTR20150629003Faculty of Medicine, Khon Kaen University50
招募中
1 期
Early Stage Follicular LymphOma and RadioTherapy PLUS anti-CD20 AntibodyEarly Stage Follicular LymphOmaCTIS2023-509278-41-00niversitaetsklinikum Heidelberg AöR130