EUCTR2010-022052-23-IT进行中（未招募）1 期
Prospective, phase II randomized study to compare busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of myelofibrosis
GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS0 个研究点目标入组 60 人开始时间: 2011年9月19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
- 60
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
- •Age = 18 = 70 years • Primary or secondary myelofibrosis after essential thrombocytemia or polycyhemia vera • One of the following unfavourable prognostic factors: - Hb < 10 g/dL - Leukocytes >25x106/L - > 1% circulating blasts in the peripheral blood - constitutional symptoms • PS (Karnofsky)= 60% • HCT-CI = 5 • Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •= 20% blasts in the peripheral blood and/or in bone marrow • Positive serologic markers for human immunodeficiency virus (HIV) • Acute hepatitis B virus (HBV) or acute hepatis C virus (HCV) infection • Severe irreversible renal, hepatic , pulmonary or cardiac disease , such as: - total bilirubin, SGOT or SGPT > 5 the upper normal limit - Left ventricular ejection fraction < 30% - Clearance creatinine < 30 ml/min - DLCO < 30% and/or receiving supplementary oxygen • Pregnancy or lactation • Patients not agreeing to take adequate contraceptive measures during the study • Psychiatric disease • Any active , uncontrolled infection 7.3 Donors: Inclusion criteria • Age = 18 < 65 years • HLA-identical sibling donor by high resolution DNA-based HLA-A, -B, -C , -DRB1 typing. • HLA-identical unrelated donor by high resolution DNA-based HLA-A, -B, -C , -DRB1 typing . One allele mismatched (class I) can be accepted for recipients up to 60 years .
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