NCT01063647已完成1 期
Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Advanced Hematological Malignancies After Treosulfan-based Conditioning Therapy - A Clinical Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 56
- 试验地点
- 13
- 主要终点
- Safety - Evaluation of feasibility and tolerability of 3 x 10, 12 or 14 g/m² Treosulfan combined with 5 x 30 mg/m² fludarabine prior to allogeneic stem cell transplantation • frequency and severity of TRM until 6 months after transplantation
研究概览
简要总结
Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a haematological chemosensitive malignancy indicated for an allogeneic transplantation, but presenting an increased toxicity risk for classical (high-dose busulfan or standard-dose total body irradiation) conditioning therapies (remission criteria ref. to Appendix L):
- •CML in first or subsequent chronic phase
- •NHL in 2nd CR/PR, chemosensitive PR after autologous transplantation ; CLL in 2nd or subsequent CR/PR
- •Relapsed Morbus Hodgkin (MH) after autologous transplantation
- •Multiple Myeloma (MM) stage II and III according to Durie and Salmon
- •AML in 2nd CR/PR or high-risk AML in 1st CR/PR
- •High-risk defined for example by the following:
- •Cytogenetics: -5/5q, -7/7q, del(5q), abnormalities of 3q, complex karyotype (> 3 abnormalities), or
- •PR after 1 cycle of induction therapy
- •ALL in 2nd CR/PR or high-risk ALL in 1st CR/PR
- •High-risk defined as follows:
- •Leukocytes > 3000/µl (B-Linage) or > 100000/µl (T-Linage);
- •Pro-B-ALL, pre-T-ALL
- •Cytogenetics: t(9;22)/BCR-ABL; t(4;11)/ALL1-AF
- •MDS (patients without prior chemotherapy may be included)
- •Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) or one mismatch (out of the 6 standard markers) sibling donor (1 misMRD):
- •HLA-identity defined by the following markers: A, B, DRB
- •DQB1 must be recorded.
- •Age > 18 years
- •Karnofsky Index > 80 %
- •Adequate contraception in female patients of child-bearing potential
- •Co-operative behavior of individual patients
- •Written informed consent
排除标准
- •Completely chemotherapy-resistant disease
- •Severe cardiac insufficiency, severe cardio-vascular or other severe concomitant diseases
- •Symptomatic malignant involvement of the CNS
- •Active infectious disease
- •HIV-positive or active hepatitis infection
- •Impaired liver function (Bilirubin > 1.5 x upper normal limit; Transaminases > 3.0 x upper normal limit)
- •Impaired renal function (Creatinine-clearance < 60 ml/min; Serum Creatinine > 1.5 x upper normal limit).
- •Pleural effusion or ascites > 1.0 L
- •Pregnancy or lactation
- •Known hypersensitivity to fludarabine and/or treosulfan
- •Parallel participation in another experimental drug trial
研究组 & 干预措施
2
Experimental
Treosulfan:12 g/m² i.v. on 3 consecutive days (day -6 to -4)
干预措施: Treosulfan (Drug)
1
Experimental
Treosulfan: 10 g/m² i.v. on 3 consecutive days (day -6 to -4)
干预措施: Treosulfan (Drug)
3
Experimental
Treosulfan: 14 g/m² i.v. on 3 consecutive days (day -6 to -4)
干预措施: Treosulfan (Drug)
结局指标
主要结局
Safety - Evaluation of feasibility and tolerability of 3 x 10, 12 or 14 g/m² Treosulfan combined with 5 x 30 mg/m² fludarabine prior to allogeneic stem cell transplantation • frequency and severity of TRM until 6 months after transplantation
时间窗: 6 months
次要结局
- Efficacy - Evaluation of the proportion of relapse- and/or progression free patients six months after transplantation (using standard remission criteria)(6 months)
研究者
研究点 (13)
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