EUCTR2008-002356-18-FR进行中（未招募）1 期
Clinical phase III trial to compare Treosulfan-based conditioning therapy with Busulfan-based reduced-intensity conditioning (RIC) prior to allogeneic haematopoietic stem cell transplantation in patients with AML or MDS considered ineligible to standard conditioning regimens. - Clinical phase III trial of Treosulfan-based conditioning vs. RIC
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
- 545
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
- •1. Patients with acute myeloid leukaemia acc. to WHO, 2001 (AML in complete remission at transplant, i.e. blast counts < 5 % in bone marrow) or myelodysplastic syndrome acc. to WHO, 2001 (MDS with blast counts < 20 % in bone marrow during disease history) indicated for allogeneic haematopoietic progenitor cell transplantation but considered to be at increased risk for standard conditioning therapies according to the following criteria:
- •- patients aged = 50 years at transplant
- •- patients with a HCT-CI score > 2 [according to Sorror et al., 2005]
- •2. Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD). Donor selection is based on molecular high resolution typing (4 digits) of class II alleles of the DRB1 and DQB1 gene loci and molecular (at least) low resolution typing (2 digits) of class I alleles (i.e., antigens) of the HLA- A, B, and C gene loci.
- •In case no class I and class II completely identical donor (10 out of 10 gene loci) can be identified, one antigen disparity (class I) and/or one allele disparity (class II) between patient and donor are acceptable. Conversely, disparity of two antigens (irrespective of the involved gene loci) cannot be accepted. These definitions for the required degree of histocompatibility apply to the selection of related as well as unrelated donors.
- •3. Adult patients of both gender, 18 – 70 years of age
- •4. Karnofsky Index = 60 %
- •5. Written informed consent
- •6. Men capable of reproduction and women of childbearing potential must be willing to consent to using a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner while on treatment and for at least 6 months thereafter.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with acute promyelocytic leukaemia with t(15;17)(q22;q12) and in CR1
- •2. Patients considered contra-indicated for allogeneic HSCT due to severe concomitant illness (within three weeks prior to scheduled day -6):
- •- patients with severe renal impairment like patients on dialysis or prior renal transplantation or S-creatinine > 3.0 x ULN or calculated creatinine-clearance < 60 ml/min
- •- patients with severe pulmonary impairment, DLCO/or FEV1 < 50 % or severe dyspnoea at rest or requiring oxygen supply
- •- patients with severe cardiac impairment diagnosed by echocardiography and LVEF < 40 %
- •- patients with severe hepatic impairment indicated by hyperbilirubinaemia > 3 x ULN or ALT / AST > 5 x ULN
- •3. Active malignant involvement of the CNS
- •4. HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
- •5. Previous allogeneic HSCT
- •6. Pleural effusion or ascites > 1.0 L
- •7. Pregnancy or lactation
- •8. Known hypersensitivity to treosulfan, busulfan and/or related ingredients
- •9. Participation in another experimental drug trial within 4 weeks prior to day –6 of the protocol
- •10. Non-cooperative behaviour or non-compliance
- •11. Psychiatric diseases or conditions that might compromise the ability to give informed consent
研究者
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