EUCTR2021-004730-11-AT进行中（未招募）1 期
A prospective, controlled, single-arm pilot study on treosulfan, fludarabine, and cyclophosphamide (TreoFC) as conditioning treatment before haploidentical hematopoietic stem cell transplantation for older patients with acute myeloid leukemia or myelodysplastic syndrome
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
- 30
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 leukemia (AML) according to WHO 2016 (AML in complete remission at transplant, i.e., blast counts <5% in bone marrow) or myelodysplastic syndrome according to WHO 2016 (MDS with blast counts <20 % in bone marrow during disease history) indicated for haploidentical HSCT but considered to be at increased risk for standard conditioning therapies according to the following criteria:
- •patients aged =50 years at transplant and/or
- •patients with an HCT-CI score >2 [according to Sorror et al., 2005]
- •2.Availability of a haploidentical (HLA match =5/10) first- or second-degree related donor. 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.
- •3.Adult patients of both gender, age 18-70 years
- •4.Karnofsky Index =60 %
- •5.Written informed consent
- •6.Men capable of reproduction and women of childbearing potential must be willing to consent to use a highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, IUDs, sexual abstinence, or vasectomized 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Availability of matched sibling donor eligible for stem cell donation
- •2.Patients with acute promyelocytic leukemia with t(15;17)(q22;q12) and in CR1
- •3.Patients considered contraindicated for HSCT due to severe concomitant illness (within 3 weeks before 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, DLCOsb (Hb-adjusted)/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 hyperbilirubinemia >3x ULN or ALT/AST >5 x ULN
- •4.Active malignant involvement of the CNS
- •5.HIV-positivity, active non-controlled infectious disease under treatment (no decrease of CRP or PCT) including active viral liver infection
- •6.Previous allogeneic HSCT
- •7.Pleural effusion or ascites > 1.0L
- •8.Pregnancy or lactation
- •9.Known hypersensitivity to treosulfan, fludarabine, cyclophosphamide and/or related ingredients
- •10.Participation in another experimental drug trial within 4 weeks before day -6 of the protocol
- •11.Non-cooperative behavior or non-compliance
- •12.Psychiatric diseases or conditions that might compromise the ability to give informed consent
研究者
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