NCT00930566Unknown1 期
Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.
研究概览
简要总结
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according to the following schedule:
Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.
Total = 8 ECP after transplantation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years and < or = 65 years with an hematological malignancy indicated for an allogeneic transplantation after reduced intensity conditioning :
- •due to the age : for patients between 55 and 65 years.
- •or for patients between 18 and 55 years of age presenting a risk of increased toxicity for myeloablative conditioning (cardiac, renal or pulmonary pathology)
- •CML and MPS in blastic phase achieving CR,
- •MM stage II or III, relapse after autologous transplant, achieving a response ≥ 30% or on first line if high risk,
- •NHL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- •CLL in 2nd CR, PR after chemotherapy or autologous transplant, chemo-sensible.
- •AML in 2nd CR or in first line for high risk criteria, secondary AML. In AML, high risk criteria are defined by : LAM 7, leukocytes>30000/mm3, cytogenetic abnormalities: t(6,9); 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q and inv 3q,
- •ALL in 2nd CR or in first line for high risk criteria defined by cytogenetic abnormalities: 11q23, t(9,22); t(1,19); t(4,11).
- •MDS patients without prior chemotherapy
- •HLA identical sibling donor
- •Performans status < or = 2
- •Patients member of a social security company
排除标准
- •Age < 18 years or > 65 years
- •Pregnant or lactating females
- •Known HIV positivity
- •Active infectious hepatitis, type A, B or C
- •Performance status > 2 according to WHO
- •Left ventricular ejection fraction < 40% and Alveolus-capillary diffusion < 50%
- •Uncontrollable hypertension with medical therapy
- •Creatinine clearance < 60 ml/min
- •Hypersensitivity or allergy to psoralen (methoxsalen)
- •Disease associated with a photosensitivity
- •Hypersensitivity or allergy to both heparin and citrate products
- •Contra-indication to Busulfan, Fludarabine, SAT or methotrexate
- •Hypersensitivity to ciclosporine, mycophenolate mofetil or mycophenolic acid
研究组 & 干预措施
Extracorporal Photopheresis
Experimental
干预措施: methoxsalen (Drug)
Extracorporal Photopheresis
Experimental
干预措施: Extracoporal Photopheresis (ECP) (Procedure)
结局指标
主要结局
Evaluation of the toxicity at Day 100 (NCI/NIH Common Toxicity Criteria) of Extracorporal Photopheresis (ECP) administered for Graft-versus-host-disease (GVHD) prophylaxis and introduced early (Day 21) after an HSCT from a genoidentical donor.
时间窗: Day 100
All types of toxicity will be assessed and graded according to NCI/NIH Common Toxicity Criteria
次要结局
- Efficacy: decrease in incidence of acute GVHD and chronic GVHD(during 2 years)
- Incidence of Infection (clinically et/or bacteriologically proved)(during 2 years)
- Documentation of chimerism [quantification of donor-type chimerism in bone marrow and/ or in peripheral blood (total blood, CD3+)](during 2 years)
- Transplant-related Mortality(at 3 months and 1 year)
- Toxicity at Day 180 after HSC transplantation(Day 180)
- Disease-free survival (DFS)(at 1 and 2 years)
- progression-free survival (PFS)(at 1 and 2 years)
- Overall survival (OS)(at 1 and 2 years)
- cumulative incidence of relapse(at 1 and 2 years)
研究者
研究点 (2)
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