NCT05621759进行中（未招募）2 期
Phase II Single-Arm Open-Label Study Of Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus for the Prevention of Graft-Versus-Host Disease (GVHD) Following Haploidentical Hematopoietic Stem Cell Transplantation (HSCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Cumulative Incidence of Grades II-IV Acute GvHD
研究概览
简要总结
This is a single arm, open label, phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive dosed reduced cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Karnofsky score ≥ 70%
- •No evidence of progressive bacterial, viral, or fungal infection
- •Creatinine clearance > 50 mL/min/1.72m2
- •Total bilirubin, Alanine Aminotransferase and Aspartate Aminotransferase < 2 x the upper limit of normal (except for diagnosed Gilbert's syndrome)
- •Alkaline phosphatase ≤ 250 IU/L
- •Left Ventricular Ejection Fraction (LVEF) > 45%
- •Adjusted Carbon Monoxide Diffusing Capacity (DLCO) > 60%
- •Negative HIV serology
- •Negative pregnancy test: confirmation per negative serum β-human chorionic gonadotropin (β-hCG) for women of childbearing age and potential.
排除标准
- •Donors are excluded in case of donor-specific HLA antibodies or positive cross-match.
- •Pregnant or nursing females or women of child bearing age or potential, who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of conditioning regimen through day +
- •A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
- •Male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).
- •Inability to provide informed consent.
- •Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix E), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- •Known allergies to any of the components of the investigational treatment regimen.
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
- •Prisoners
研究组 & 干预措施
Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus
Experimental
Participants to receive:
- Cyclophosphamide 25 mg/kg IV over 1 hour on Day 3 and Day 4 following transplant
- Abatacept 10 mg/kg IV on Day 5, Day 14, Day 28, and Day 56 following transplant
- Tacrolimus 0.02 mg/kg IV by continuous infusion, starting on Day 5 following transplant. May switch to oral administration when tolerated, adjusted to maintain a drug level between 5-12ng/mL. Tacrolimus treatment is continued until Day 60 and then tapered over a period of 4 weeks in the absence of GvHD.
干预措施: Cyclophosphamide (Drug)
Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus
Experimental
Participants to receive:
- Cyclophosphamide 25 mg/kg IV over 1 hour on Day 3 and Day 4 following transplant
- Abatacept 10 mg/kg IV on Day 5, Day 14, Day 28, and Day 56 following transplant
- Tacrolimus 0.02 mg/kg IV by continuous infusion, starting on Day 5 following transplant. May switch to oral administration when tolerated, adjusted to maintain a drug level between 5-12ng/mL. Tacrolimus treatment is continued until Day 60 and then tapered over a period of 4 weeks in the absence of GvHD.
干预措施: Abatacept (Drug)
Reduced-Dose Post-Transplant Cyclophosphamide, Abatacept, and Short-Duration Tacrolimus
Experimental
Participants to receive:
- Cyclophosphamide 25 mg/kg IV over 1 hour on Day 3 and Day 4 following transplant
- Abatacept 10 mg/kg IV on Day 5, Day 14, Day 28, and Day 56 following transplant
- Tacrolimus 0.02 mg/kg IV by continuous infusion, starting on Day 5 following transplant. May switch to oral administration when tolerated, adjusted to maintain a drug level between 5-12ng/mL. Tacrolimus treatment is continued until Day 60 and then tapered over a period of 4 weeks in the absence of GvHD.
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Cumulative Incidence of Grades II-IV Acute GvHD
时间窗: Up to Day 120
The first day of acute GvHD of any grade is used to calculate the cumulative incidence for that grade. The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
次要结局
- Cumulative Incidence of Chronic GvHD(Up to Day 365)
- Number of Participants Presenting with Primary Graft Failure(Up to Day 45)
- Number of Participants Presenting with Poor Graft Function(Up to Day 30)
- Number of Participants Presenting with Secondary Graft Failure(Up to Day 730)
- Treatment-Related Mortality (TRM) Rate(Up to Day 730)
- Relapse Rate (RR)(Up to Day 730)
- Overall Survival (OS) Rate(Up to Day 730)
- GvHD and Relapse-Free Survival (GRFS) Rate(Up to Day 730)
研究者
研究点 (1)
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