2024-516435-27-00招募中2 期
AAA-IPC 2011-003 - Prospective and multicentre evaluation of 3 different doses of IV busulfan associated with fludarabine and thymoglobuline in the conditioning of allogeneic stem cell transplantation (SCT) from a matched related or unrelated donor in patients with poor prognosis myeloïd malignancies
Institut Paoli Calmettes17 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2024年11月5日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 177
- 试验地点
- 17
- 主要终点
- Time to progression or death
研究概览
简要总结
To assess the 2-year progression free survival rates in patients with high-risk myeloid ma-lignancies following HSCT using different dose levels of IV Busulfan (BX3 and BX4) com-bined with fludarabine and thymoglobuline as conditioning therapy
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（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with poor prognosis myeloid malignancies in particular : myelodysplasic syndrome, AML beyond CR1 regardless of the cytogenetic or molecular abnormalities or CR1 AML after double induction regardless of the cytogenetic or molecular abnormalities or CR1 AML with no criteria for favorable risk according to the ELN classification
- •Adult patients aged ≥ 50 years up to 65 or < 50 years not eligible for myeloablative conditioning regimen based on TBI or double alkylating agent combinations
- •Availability of a HLA identical sibling or matched unrelated donor (10/10)
- •Affiliation to social security
- •Written Informed Consent
排除标准
- •History of previous Allo-HSCT
- •HIV positivity
- •Signs of chronic active hepatitis B and/or C
- •Evolutive psychiatric disease
- •Concomitant neoplasic disease
- •Pregnant or lactating woman or without contraception (for child bearing potential women)
- •Usual contra-indications for Allo-HSCT
结局指标
主要结局
Time to progression or death
Time to progression or death
次要结局
- Time to death and cause of death
- Time to acute and chronic GVHD according to the NIH classification and relapse
- Response to treatment
- Hematological recovery defined as the achievement 500 ANC and 50 000 platelets (without transfusion)
- Full donor chimerism achievement at M1, M2, M3
- Occurrence of grade 3-4 adverse events according the CTC AE v4.0 scale within 6 months after conditionning
研究者
Pr Didier BLAISE
Scientific
Institut Paoli Calmettes
研究点 (17)
Loading locations...
相似试验
招募中
1 期
Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute ConditionsAutoimmune DiseasesCardiovascular DisordersDiabetes ComplicationsIntegumentary DiseaseMusculoskeletal DisordersNeurodegenerative DisordersNeurologic DisordersPulmonary DisordersUrologic DisordersViral IllnessSexual DysfunctionNCT04684602Thomas Advanced Medical LLC5,000
已完成
3 期
Comparison of Peripheral Blood Stem Cell Transplantation With Bone Marrow Transplantation for the Treatment of Serious Hematological MalignanciesBlood Stem Cell TransplantNCT00275678Mayo Clinic15
终止
2 期
Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRICGraft Versus Host DiseaseNCT03263767Nantes University Hospital47
撤回
1 期
Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Pulmonary EmphysemaPulmonary EmphysemaNCT01849159Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Unknown
不适用
Comparison of New-onset Diabetes After Transplantation Between Two Steroid Withdrawal Group With CellCeptDiabetesNCT02095418Samsung Medical Center152