EUCTR2005-005187-90-SK进行中（未招募）1 期
A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Aggressive B-cell lymphoma:NHL-13 - NHL-13 (ML18223)
AGMT: Arbeitsgemeinschaft Medikamentöse Tumortherapie0 个研究点目标入组 600 人开始时间: 2007年1月15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
- 600
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 must have received eight infusions of rituximab plus 4 – 8 cycles of CHOP-like chemotherapy including an anthracycline
- •Induction treatment must have been completed with the application of the final cycle of chemotherapy or immunotherapy no longer than 12 weeks, and no earlier than 4 weeks before trial treatment start.
- •Patients must have reached a complete remission (CR) or an unconfirmed CR (CRu) after induction therapy
- •Histologic diagnosis of either diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma grade 3b according to the WHO/REAL classification at time of diagnosis (prior to induction therapy)
- •Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy)
- •ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV )
- •Known IPI at time of diagnosis (prior to induction therapy)
- •Age 18 years or older
- •Life expectancy of at least 3 months
- •Be willing and able to comply with the protocol for the duration of the study
- •Women of child-bearing potential must have a negative pregnancy test and must agree to use effective contraception for the entire treatment period and during the 12 months thereafter.
- •Patient’s 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •First-line NHL therapy other than specified in the inclusion criteria
- •More than one prior chemoimmunotherapy regimen.
- •Histologies other than DLBCL and follicular lymphoma grade 3b according to the WHO/REAL classification
- •Transfomed lymphoma
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.
- •Major surgery, other than diagnostic surgery, within the last 4 weeks.
- •Evidence of CNS involvement. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant and adversely affecting compliance to study drugs.
- •Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months.
- •Unacceptable hematologic status at baseline prior to study start below any of the values listed: WBC: <3 x 109/L; absolute neutrophil count (segmented + bands) <1.5 x 109/L; platelets: <100 x109/L
- •Abnormal liver function tests prior to study start above any of the values listed: serum bilirubin >2 mg/dL (35 mmol/L); ALAT or ASAT >2.5 x upper limit of normal range; alkaline phosphatase > 3 x upper limit of normal range
- •Abnormal renal function (serum creatinine > 2.0 mg/dL (177 µmol/L)).
- •Patients with active opportunistic infections.
- •HIV-positive patients.
研究者
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