EUCTR2011-003494-29-DE进行中(未招募)1 期
FLT-PET vs FDG-PET Response Assessment in Diffuse Large B-cell Lymphoma - FLT Therapy Monitoring
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 137
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
- •All patients must have a histologic or cytological diagnosis DLBCL (including lymphomas/leukemias that newly transformed into DLBLC ) and be scheduled or currently be receiving the first cycle of first line chemotherapy with :
- •a)R-CHOP or R-EPOCH given every 21 days (R-CHOP-21 or R-EPOCH-21) which is taken for 4 weeks of their FDG-PET/CT and for 6 cycles or.
- •b)R-CHOP given every 21 days (R-CHOP-21) within 8 weeks of their enrollment and for 8 cycles or
- •c)R-CHOP-14 or R-EPOCH-14 (R-CHOP or R-EPOCH given every 14 days; between cycle 2 and 3 no CSF-administration for 21 days) within 6 weeks of their enrollment and for 6 cycles
- •Patients undergoing consolidative external radiotherapy at the end of all 6 cycles of R-CHOP or R-EPOCH are eligible.
- •Patients must be =18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
- •Patients must sign an informed consent, and be mentally responsible.
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
- •Expected non-compliance
- •Patients unwilling or unable to give informed consent
- •Participation on another clinical trial within the last 3 months
研究者
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