NCT00129155Unknown2 期
Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall survival at 1 year
研究概览
简要总结
In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant.
The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell.
The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •AGE: >= 18 years and <= 65 years
- •Patients with a too high transplant-related mortality (TRM) after standard transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma, myelodysplasia)
- •Patients with visceral contra-indication for standard transplantation:
- •cardiac: myocardiopathy; forced expiratory volume (FEV) < 50%;
- •respiratory: abnormal carbon monoxide diffusing capacity (DLCO);
- •renal: creatinine clearance < 50ml/min;
- •hepatic: transaminases and bilirubin > 2 upper normal limit;
- •infectious: controlled fungal infection.
- •Karnofsky score >= 70%
- •Unrelated donor HLA identical (ABC, DRB1; DQB1)
- •Signed informed consent
- •Diagnosis :
- •Chronic myelogenous leukemia (CML):
- •In first chronic phase, resistant to interferon with or without aracytine or refractory or resistant to Glivec
- •In complete response (CR) or in 2nd partial response (PR) after being in blastic phase
- •Multiple myeloma (MM):
- •Relapse after autograft if the therapeutic response was evaluated to 50%
- •Non-Hodgkin's lymphoma (NHL):
- •Mantle cell lymphoma after first relapse but in case of chemosensitivity ≥ 50% except for high grade lymphoma
- •In 2nd CR or PR chemosensitive in response ≥ 50% after autograft
- •Chronic lymphocytic leukemia (CLL):
- •In 2nd CR or PR or in response ≥ 50% after autograft or in 2nd relapse after 2 lines of treatment but in case of chemosensitivity ≥ 50%
- •Acute myeloid leukemia (AML):
- •In 2nd CR or in 1st CR for high risk criteria [high risk criteria defined by: LAM 7; leukocytes > 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q]
- •Acute lymphoblastic leukemia (ALL):
- •In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23
- •Myelodysplastic syndromes (MDS):
- •Patients without prior chemotherapy, with intermediate or high International Prognostic Scoring System (IPSS) score and blast cells < 1% in bone marrow (BM)
- •CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM
- •Secondary AML patients with a response to chemotherapy (< 30% blasts in BM and < 5% of blast cells in blood)
- •Adequate contraception in female patients of child bearing potential
排除标准
- 未提供
结局指标
主要结局
Overall survival at 1 year
次要结局
- Acute and chronic graft-versus-host disease incidence and severity
- Evaluation of conditioning and transplant toxicity
- Chimerism evaluation
- Response rate and survival without progression
- Engraftment evaluation
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC)Acute Myeloid LeukemiaMyelodysplastic SyndromeNCT00822393medac GmbH570
已完成
2 期
Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCTMultiple MyelomaNCT00599495Universitätsklinikum Hamburg-Eppendorf50
已完成
2 期
Allogeneic Stem Cell Transplantation (SCT) After Dose-reduced Conditioning for Myelofibrosis PatientsMyelofibrosisNCT00599547Universitätsklinikum Hamburg-Eppendorf106
已完成
1 期
Development of treosulfan-based conditioning regimen for congenital metabolic diseases; Phase I studyMucopolysaccharidosis type I (Herler syndrome), type II (Hunter syndrome)JPRN-UMIN000009758Tokai University School of Medicine12
已完成
2 期
Allogeneic Stem Cell Transplantation (SCT) With Treosulfan, VP-16 and Cyclophosphamid for Patients With Acute Lymphoblastic Leukemia (ALL)Acute Lymphoblastic LeukemiaNCT00682305Universitätsklinikum Hamburg-Eppendorf50