NCT00980304Unknown2 期
A Multicenter, Open Label, Phase II Trial of Rituximab in Combination With ICE as Salvage Therapy in the Relapsed DLBCL Patients After 1st Line Induction Treatment of 6-8 Cycles of RCHOP-LIKE Chemo
Shanghai Jiao Tong University School of Medicine0 个研究点开始时间: 2009年9月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
研究概览
简要总结
It is a phase II , multicenter, open label clinical trial. Only the relapsed DLBCL patients after 1st line induction treatment of 6~8 cycles of RCHOP-like chemo will be enrolled to receive 3 cycles of RICE as salvage therapy.
After treatment each patient should be followed up for 2 years.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed DLBCL patients having received 6 - 8 cycles of RCHOP-like chemotherapy as 1st line induction treatment.
- •Disease relapsed no earlier than 6 months after prior induction treatment.
- •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 and <65 y
- •Life expectancy of > 3 months
- •Be willing and able to comply with the protocol for the duration of the study
- •Agree to use effective contraception for the entire treatment period and during the 12 months thereafter
- •Patient's written informed consent
排除标准
- •More than one prior chemoimmunotherapy regimen.
- •Histologies other than DLBCL according to the WHO/REAL classification
- •History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin, surgically treated malignant melanoma 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
- •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 (30 mmol/L); ALAT or ASAT >2.5 x upper limit of normal range; or Abnormal renal function (serum creatinine > 150 μmol/L ).
- •HIV-positive patients.
- •Contraindication to the investigational medication
- •Active viral hepatitis, specifically HBV or HCV infection
- •Serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease)
- •Life expectancy < 3 months
- •Treatment within a clinical trial within 30 days prior to trial entry
- •Women who are breast feeding, are not using effective contraception, are pregnant
- •Patients under tutelage
研究组 & 干预措施
Rituximab in combination with ICE as salvage therapy
Experimental
干预措施: Rituximab (Drug)
研究者
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