EUCTR2005-003479-19-GB进行中（未招募）1 期
A Phase II Single Arm Study of the use of CODOX-M/IVAC with Rituximab (R-CODOX-M/IVAC) in the treatment of patients with Diffuse Large B-Cell Lymphoma (DLBCL) or Burkitt's Lymphoma (BL) of International Prognostic Index (IPI) High or High-Intermediate Risk - R-CODOX-M/IVAC
niversity College London0 个研究点目标入组 150 人开始时间: 2005年10月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
入选标准
- •a) Age 18-65 years (inclusive)
- •b) Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) and all morphological variants or Burkitt’s lymphoma, according to the current World Health Organisation classification1. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel.
- •c) IPI score high-intermediate (score=3) or high (score=4, 5). IPI defined as stage III or IV, raised LDH, > 1 extranodal site and poor performance status – WHO performance status >/= 2.
- •d) Patients with a positive serology for HIV
- •'There is increasing evidence of equivalent outcomes in HIV negative and positive individuals so it is no longer appropriate to exclude all patients who are HIV positive from entry into this study. However there are also grounds for believing that some HIV positive patients with poor immunological function and / or poor performance status may be put at risk with this very intensive programme of chemo-immunotherapy. Therefore for patients known to be HIV positive only patients with one or none of the following criteria will be eligible
- •1. CD4 cell count less than 100/_L,
- •2. Prior history of opportunistic infections,
- •3. Karnofsky performance score less than 60 or Eastern Cooperative Oncology Group score (ECOG) > 2
- •e) Disease stage II - IV
- •f) No previous chemotherapy, radiotherapy or other investigational drug for this indication (although pre-treatment with steroids is acceptable)
- •g) Adequate bone marrow function with platelets > 100x109/l; neutrophils > 1.5x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma.
- •h) Serum creatinine < 150 micromol/l, serum bilirubin < 35micromol/l and transaminases < 2.5 x upper limit of institutional normal range unless attributed to lymphoma.
- •i) Normal MUGA or echocardiogram without areas of abnormal contractility and normal left ventricular ejection fraction (LVEF). (Only applicable if over 60 years of age, past history of diabetes, cardiac disease, hypertension or abnormal resting ECG).
- •j) No concurrent uncontrolled medical condition.
- •k) No active malignant disease other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the last 10 years.
- •l) Life expectancy > 3 months.
- •m) Adequate contraceptive precautions for all patients of childbearing potential.
- •n) Written, informed consent.
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a) Disease stage I
- •b) T-cell lymphoma.
- •c) Previous history of treated or non-treated indolent lymphoma. However, diffuse large B cell patients not previously diagnosed who have some small cell infiltration in bone marrow or lymph node may be included.
- •d) Past history of heart failure or uncontrolled angina pectoris.
- •e) Cardiac contra-indication to doxorubicin (abnormal contractility on echocardiography or nuclear medicine examination [MUGA]).
- •f) Neurological contra-indication to vincristine (e.g. pre-existing diabetic neuropathy).
- •g) Any other serious active disease.
- •h) General status that does not allow the administration of 2 cycles of CODOX-M/IVAC according to the investigator.
- •i) Patients with a positive serology for HIV not satisfying the inclusion criteria in section 5.3.1, Hepatitis B or Hepatitis C
- •j) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
研究者
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