2023-506648-18-00招募中2 期
CASPER-ATG-IPC 2023-015 : 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-Calmettes1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年6月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.
研究概览
简要总结
To assess efficacy of enhanced GVH prophylaxis with low-dose ATG administered at the time of neutrophil recovery after haplo-identical allogeneic transplantation.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •adult with age ≥ 60 or aged 50 to 59 with comorbidities (HCT-CI10 score ≥ 3)
- •haematological malignancies except for myeloproliferative syndrome and myelodysplastic syndrome
- •Patient having received an allograft within ≤ 35 days, performed with the following modalities: o First allogeneic transplant, o Haploidentical donor, o Peripheral stem cell transplant, o Non-myeloablative "Baltimore"-type conditioning, delivered as standard in routine care, as reported in the literature (fludarabine, cyclophosphamide, total body irradiation), o Standard GVH 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 transplant or organ transplant
- •presence of GVH
- •contraindication 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
- •Person in an emergency situation 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
Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.
Evaluate the rate of grade 2-4 acute GVH at D100 post allograft using the MAGIC7 classification.
次要结局
- Grade 2-4 acute GVH will be assessed using the MAGIC7 classification at D30, D60, D90, D100, D120, D180, D270 and at D365 post allograft
- Chronic GVH will be assessed using NIH8 classification at D100, D120, D180, D270 and at D365 post allograft
- Cumulative incidence of chronic GVH at 1 year post-transplant
- Cumulative incidence of non-relapse mortality (NRM) at 1 year post-transplant
- Cumulative incidence of relapse at 1 year post-transplant
- Blood T, B and NK lymphocyte counts at D30, D60, D90, D120 and D180 post-transplant
- Cumulative incidence of invasive fungal and viral infections (CMV, EBV, BK virus) between D30 and D120 post allograft
- Cumulative incidence of EBMT-defined "poor graft function" at D100 post-transplant
- Progression-free survival at 1 year post-transplant
- Overall survival at 1 year post-transplant
- Quality of life: assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire.
研究者
Dr Benjamin BOUCHACOURT
Scientific
Institut Paoli-Calmettes
研究点 (1)
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