NCT06066255Unknown2 期
REINFORCED PROPHYLAXIS OF GVH IN ELDERLY PATIENTS WITH HAEMATOLOGICAL MALIGNANCIES RECEIVING HAPLOIDENTICAL ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: USE OF A LOW DOSE OF POST-ALLOGRAFT ANTI-LYMPHOCYTIC SERUM
Institut Paoli-Calmettes0 个研究点目标入组 27 人开始时间: 2024年3月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 27
- 主要终点
- Rate of acute GVH
研究概览
简要总结
The aim of this trial is to evaluate the efficacy of GVH prophylaxis reinforced by low-dose Thymoglobulin administered at the end of aplasia after haploidentical allogeneic transplantation.
Patients will receive a single infusion of Thymoglobulin at a dose of 1 mg/kg between 48h and 72h after emergence from aplasia, and will be followed for 12 months.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3),
- •Hematological malignancies except myeloproliferative syndrome and myelodysplastic syndrome,
- •Patient having received an allograft within ≤ 35 days, performed with the following modalities:
- •First allogeneic transplant,
- •Haploidentical donor,
- •Peripheral stem cell transplant,
- •Non-myeloablative "Baltimore"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation),
- •Standard GVHD prophylaxis in the context of haploidentical transplants (post-transplant cyclophosphamide, ciclosporin A and mycophenolate mofetil).
- •Patient discharged from aplasia within ≤ 35 days,
- •Signed informed consent form,
- •Affiliation with a social security.
排除标准
- •Previous allogeneic or organ transplant,
- •Presence of signs of GVHD,
- •Contraindications to treatment with Thymoglobuline®,
- •Hypersensitivity to rabbit proteins or to any of the excipients listed in the "Composition" section of the summary of product characteristics,
- •Pregnant women or may become pregnant (without effective contraception) or breast-feeding,
- •Persons in emergency situations or unable to give informed consent form,
- •Adult with a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
- •Unable to comply with medical follow-up for geographical, social or psychological reasons.
结局指标
主要结局
Rate of acute GVH
时间窗: Day 100
To assess the rate of grade 2-4 acute GVHD post allograft using the MAGIC classification.
次要结局
- Cumulative incidence of chronic GVH(1 year)
- Cumulative incidence of relapse(1 year)
- Survival(1 year)
- chronic GVH(day(D)100, D120, D180, D270 and D365)
- Acute GVH(day(D) 30, D60, D90, D100, D120, D180, D270 and D365)
- Cumulative incidence of NRM(1 year)
- Immunology(day(D)100, D120, D180, D270 and D365)
- Cumulative incidence(Day 100)
- Viral infections(between day (D)30 and D120)
研究者
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