jRCT2011210064招募中不适用
A phase 2/3, Multicenter, randOmized, Double-blind, placebo-controlled, stUdy to evaLuate the safety and efficacy of Alpha-1 AntiTrypsin for the prEvention of graft-versus-host disease in patients receiving hematopoietic cell transplant (MODULAATE Study) (MODULAATE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 310
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female participants, >=12 years of age (>= 18 years of age for participants at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.
- •Planned myeloablative conditioning regimen.
- •Participants must have a related or unrelated donor as follows:
- •Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing.
- •Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing.
排除标准
- •Prior autologous or allogeneic HCT.
- •T cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti thymocyte globulin [ATG], alemtuzumab) for GVHD prophylaxis.
- •Planned umbilical cord blood transplant.
- •Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
- •Planned haploidentical donor.
结局指标
主要结局
-
Grade II-IV aGVHD-free survival through 180 days after HCT
次要结局
- Incidence of lower gastrointestinal (GI) aGVHD or Grade III-IV aGVHD in any organ(180 days after HCT)
- Incidence of severe infections(100 and 180 days after HCT)
- Incidence of Grade II-IV aGVHD or death(100 and 180 days after HCT)
- Incidence of lower GI aGVHD(60, 100, and 180 days after HCT)
- Incidence of all-cause mortality, relapse-related and non-relapse-related mortality(180, 365, and 730 days after HCT)
- Incidence of Grade III-IV aGVHD(60, 100 and 180 days after HCT)
- Incidence of moderate to severe chronic GVHD(180, 365, 545, and 730 days after HCT)
- Incidence of discontinuation of immune suppression(180 and 365 days after HCT)
- Time to neutrophil engraftment
- GVHD-relapse free survival(365 and 730 days after HCT)
- Incidence of relapse of primary malignancies(180, 365, and 730 days after HCT)
- Incidence of overall response, complete response and partial response among subjects with Grade II-IV aGVHD
- Incidence of investigational product-related AEs
- Pharmacokinetic parameters
研究者
相似试验
尚未招募
3 期
The effect of alpha-1-antitrypsin on the progression of covid-19 diseaseIRCT20110510006431N6Shahid Beheshti University of Medical Sciences50
已完成
1 期
The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 DiabetesDiabetesType 1 DiabetesNCT01319331University of Colorado, Denver12
已完成
不适用
Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary EmphysemaPulmonary EmphysemaNCT02382367Hospices Civils de Lyon190
终止
1 期
A Research Trial of Aralast in New Onset Diabetes (RETAIN)Diabetes Mellitus, Type 1NCT01183468National Institute of Allergy and Infectious Diseases (NIAID)17
Unknown
1 期
Single Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac SurgeryPost Cardiac Surgery Systemic Inflammatory ResponseNCT02191839Soroka University Medical Center20