A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Adult Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for haplo-HSCT in adult ALL patients, with the goal of improving patient quality of life and survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent: Participants must voluntarily sign a written informed consent form.
- •Age and Gender: Participants should be male or female, aged 18-65 years, inclusive.
- •Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to adults aged 18-65 years.
- •Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.
- •Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).
- •Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:
- •Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.
- •Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.
- •Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml/min.
- •Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.
- •Reproductive Health:
- •Women of childbearing potential must test negative for pregnancy with a Human Chorionic Gonadotropin (HCG) test, confirmed by immunofluorescence during both screening and baseline periods. They must also agree to use effective contraception for at least one year following the transplantation.
- •Male participants with female partners of childbearing potential must agree to use effective barrier contraception and refrain from sperm donation for at least one year following the transplantation.
排除标准
- •To be eligible for inclusion in the study, participants must not meet any of the following criteria:
- •The patient has not achieved hematologic remission before transplantation.
- •The patient has chosen a non-haploidentical related donor.
- •The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.
- •The patient has an active or refractory infection, or other life-threatening complications.
- •The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.
- •The patient refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.
- •The investigator deems the patient unsuitable for participation in the study for any other reason.
研究组 & 干预措施
TBI conditioning group
Total Body Irradiation (TBI) plus Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
TMLI conditioning group
Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) plus Cyclophosphamide
干预措施: TMLI (Radiation)
TMLI conditioning group
Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI) plus Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
TBI conditioning group
Total Body Irradiation (TBI) plus Cyclophosphamide
干预措施: TBI (Radiation)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: 2 years
RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint.
acute Graft Versus Host Disease (aGVHD)
时间窗: 100 days
The incidence of aGVHD within 100 days post-transplant.
Overall Survival (OS)
时间窗: 2 years
OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint.
次要结局
- Relapse Rate (RR)(2 years)
- Transplantation Related Mortality (TRM)(100 days)
- Conditioning-related Adverse Events (CRAE)(30 days)
研究者
Xiangbo Wan
Professor
The First Affiliated Hospital of Zhengzhou University