EUCTR2006-002971-42-IT进行中（未招募）不适用
Outpatients high-dose chemotherapy supported by autologus peripheral blood stem and single-dose pegfilgrastim in patients with lymphoproliferative malignances. - ND
OSPEDALE S. RAFFAELE0 个研究点开始时间: 2007年7月6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
- •Patients with lymphoid malignancies (diffuse large cell
- •lymphoma-DLCL, Hodgkin lymphoma, chronic lymphocytic
- •leukemia-CLL, multiple myeloma-MM or other lymphoid
- •malignancies indicated for autologo transplantation).
- •2. Target graft size (unmanipulated)
- •- peripheral blood: 4 - 10 x 106 CD34+ cells/kg BW recipient
- •3. Age > 18 and < 65 years
- •4. Karnofsky Index > 80 %
- •5. 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Secondary malignancies
- •2. Severe concomitant illnesses / medical conditions (e.g.
- •impaired respiratory and/or cardiac function)
- •3. Active infectious disease
- •4. HIV- positivity or active hepatitis infection
- •5. Impaired liver function (Bilirubin > upper normal limit;
- •Transaminases > 3.0 x upper normal limit)
- •6. Impaired renal function (Creatinine-clearance < 60 ml/min;
- •Serum Creatinine > 1.5 x upper normal limit).
- •7. Pleural effusion or ascites > 1.0 L
- •8. Pregnancy or lactation
- •9. Known hypersensitivity to Pegfilfrastim
- •10. Participation in another experimental drug trial within 4 weeks
- •before day -6
- •11. Non-co-operative behaviour or non-compliance
- •12. Psychiatric diseases or conditions that might impair the ability
- •to give informed consent
研究者
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