2023-510441-24-00进行中（未招募）3 期
Graft vs Host Disease Prophylaxis in unrelated donor transplantation: a randomized clinical trial comparing PTCY vs ATG
DKMS Group gGmbH24 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2024年9月20日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
- 试验地点
- 24
- 主要终点
- (1) overall survival (OS) from randomization, and (2) graft-versus-host disease-free and relapse-free survival (GRFS) from time of transplantation.
研究概览
简要总结
One of the key elements to improve allogeneic HCT is the administration of optimized conditioning treatment including immunosuppressive drugs to facilitate engraftment, prevent GVHD and induce tolerance of donor immune cells. Specifically, the goal of this trial is to investigate the impact of PTCY versus ATG Grafalon ® as part of a conditioning treatment for alloHCT on overall survival (OS) and on graft-versus host disease-free and relapse-free survival (GRFS). Information on the investigational drugs provided by these two endpoints will enable the scientific community a comprehensive assessment of the two approaches for alloHCT.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed written Informed Consent and able to understand the nature of the trial and the trial related procedures and to comply with them (see Section 24.3). − Age ≥ 18 years. − One of the following eligible diagnoses: - AML in CR1 with intermediate or adverse risk genetic abnormalities (according to the ELN 2022 guidelines1), or undefined risk. - AML of any ELN risk category after hematological or molecular relapse0F a, or with primary refractory disease. - AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative neoplasia, except if favourable genetic abnormalities (according to ELN 2022 guidelines1) are present. - Therapy-related myeloid neoplasia (t-MN), except if favourable genetic abnormalities (according to ELN 2022 guidelines1) are present. - MDS with intermediate risk, high risk or very high risk disease according to the IPSS-R Score or MDS with moderate high, high, or very high risk disease according to the IPSS-M Score2 regardless of treatment status. - MDS/MPN and CMML-1/CMML-2 according to WHO 20223 regardless of treatment status. − The left ventricular ejection fraction (LVEF) was ≥40% at last assessment. − Planned transplantation with Peripheral Blood Stem Cells (PBSC). − Transplantation scheduled to be performed 4 to 14 days after date of randomization. − The scheduled donor is unrelated to the patient, and matched or partially matched (with not more than one allele or antigen mismatch) at HLA-A, -B, -C, or -DRB
- •− Absence of pregnancy confirmed by highly sensitive pregnancy test for WOCBP (see Section 17.7). Test must not date back - more than 3 days prior to randomization, or - more than 3 days prior to start of conditioning, if it started before randomization.
排除标准
- •− Anamnestic intravenous or subcutaneous exposure to rabbit immunoglobin-preparations (e.g. Grafalon or Thymoglobulin ) − Known hypersensitivity to ATG Grafalon ® or its excipients. − Known hypersensitivity to cyclophosphamide, its metabolites or excipients. − Prior allogeneic hematopoietic transplantation. − Patients who receive supplementary continuous oxygen at the time of randomization. − Symptomatic heart failure (NYHA ≥2) at the time of randomization. − Uncontrolled viral, bacterial or fungal infection with progression or no clinical improvement at the time of randomization. − Symptomatic cystitis or known obstruction of urine flow at the time of randomization. − Breast-feeding women. − WOCBP and fertile male patients unable or unwilling to follow highly effective contraception methods from enrollment to minimum six months after the last dose of the IMP (see Section 17.7). − Simultaneous participation in another interventional clinical trial with an investigational medicinal product.
结局指标
主要结局
(1) overall survival (OS) from randomization, and (2) graft-versus-host disease-free and relapse-free survival (GRFS) from time of transplantation.
(1) overall survival (OS) from randomization, and (2) graft-versus-host disease-free and relapse-free survival (GRFS) from time of transplantation.
次要结局
- − Overall survival from HCT. − Relapse- and immunosuppression-free survival (RIFS) from HCT. − Event-free survival (EFS) from HCT. − Cumulative incidences of relapse from HCT. − Cumulative incidences of non-relapse mortality (NRM) from HCT, etc. (s.protocol section 10.2).
研究者
Sarah Trost
Scientific
DKMS Group gGmbH
研究点 (24)
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