NCT07588594招募中不适用
Prospective Single-Arm Clinical Study of Thiotepa-Containing Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 1
研究概览
简要总结
This is a prospective, single-arm clinical study. It aims to evaluate the effectiveness and safety of a conditioning regimen containing thiotepa (in combination with busulfan and fludarabine, with or without ATG) of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with chronic myelomonocytic leukemia (CMML) who have an intermediate-2 or high-risk prognosis.
The main goal is to evaluate 1 year RFS and OS. Other goals include assessing engraftment, overall survival, transplant-related complications, and side effects. A total of 31 participants will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥ 18 years, any sex/gender.
- •Confirmed diagnosis of chronic myelomonocytic leukemia (CMML) according to the 2022 WHO classification.
- •Intermediate-2 or high-risk CMML based on CPSS or CPSS-mol score, and planned to receive allo-HSCT.
- •Has a suitable hematopoietic stem cell donor:
- •For haploidentical donor: at least 5/10 HLA match at HLA-A, -B, -C, -DQB1, and -DRB
- •For unrelated donor: at least 9/10 HLA match at the same five loci.
- •For matched sibling donor: 10/10 HLA match at the same five loci.
- •Hematopoietic cell transplantation comorbidity index (HCT-CI) ≤ 2, with generally good health and no significant organ abnormalities or major comorbidities.
- •Adequate organ function as defined below:
- •Left ventricular ejection fraction (LVEF) ≥ 50%, and no uncontrolled tachycardia or bradycardia-tachycardia syndrome.
- •Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2 × ULN; AST ≤ 2 × ULN.
- •Serum creatinine ≤ 1.5 × ULN.
- •Baseline oxygen saturation > 92%.
- •Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40%, FEV1 ≥ 50%.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Agrees not to participate in any other interventional study during the treatment period.
- •Willing and able to provide written informed consent, understand the nature, purpose, and procedures of the study, and voluntarily comply with study requirements.
排除标准
- •Previous allogeneic HSCT for CMML that later relapsed.
- •Unwilling or unable to receive the study treatment regimen.
- •Active hepatitis B or C, or chronic active hepatitis; known human immunodeficiency virus (HIV) infection.
- •Active uncontrolled infection, including: hemodynamic instability related to infection, new or worsening signs/symptoms of infection, new infection lesions on imaging, or persistent fever without explanation despite no symptoms/signs.
- •History of stroke or intracranial hemorrhage within 6 months before enrollment.
- •Known pregnancy (positive urine pregnancy test), or currently breastfeeding.
- •Diagnosis of another malignancy within the past 2 years, except for localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, breast cancer, or localized prostate cancer (Gleason score ≤ 6) that has been treated with curative intent.
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
研究组 & 干预措施
Single Arm: Thiotepa + Busulfan + Fludarabine ± ATG
Experimental
Patients with intermediate-2 or high-risk chronic myelomonocytic leukemia (CMML) per CPSS/CPSS-mol criteria, who are scheduled to receive allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a thiotepa-containing conditioning regimen.
干预措施: TBF regimen (Drug)
研究者
Sun Yuqian
Principal Investigator
Peking University People's Hospital
研究点 (1)
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