EUCTR2011-001534-42-IT进行中（未招募）1 期
Treosulfan and 4 Gy TBI based conditioning with Rapamycin-based GvHD prophylaxis for allogeneic stem cell transplantation in patients with haematological malignancies
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 个研究点目标入组 67 人开始时间: 2012年5月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with hematological malignancies such as
- •- acute myeloid leukaemia -AML- in CR1 except low-risk
- •cases” defined by: t(15;17); t(8;21); inv 16; normal cytogenetics
- •at diagnosis with FLT3-ITD negative and NPM-1 positive (with
- •any high-risk clinical criteria).
- •- any AML beyond CR1
- •- acute lymphoblast leukaemia -ALL- in CR1 only if at high
- •risk” defined by cytogenetics as t(9;22), t(4;11), or for
- •persistence of minimal residual disease (MRD) after
- •consolidation.
- •- any ALL beyond CR1
- •- chronic myeloid leukaemia -CML- in chronic phase (CP) or
- •accelerated phase (AP) intolerant/not responsive to TKinhibitors,
- •in blastic phase (BP)
- •- myeloproliferative neoplasia –MPD-
- •- myelodysplastic syndrome -MDS- with intermediate or high
- •risk International Prognostic Scoring System (IPSS)
- •- diffuse large cell lymphoma –DLCL- with a chemosensitive
- •relapse or beyond CR1
- •- lymphoblastic and Burkitt lymphoma with a chemosensitive
- •relapse or beyond CR1
- •- mantle cell lymphoma –MCL- with a chemosensitive relapse
- •or beyond CR1
- •- follicular lymphoma –FCL- with a chemosensitive relapse or
- •- Hodgkin lymphoma -HD- with a chemosensitive relapse or
- •- chronic lymphocytic leukaemia –CLL- at poor risk” in CR1 or
- •with a chemosensitive relapse
- •- T-cell non Hodgkin lymphoma –T-NHL- in CR1 or beyond
- •- multiple myeloma –MM- at high risk for cytogenetics or ISS
- •stage 3 in CR1 following high dose chemotherapy
- •- MM at any relapse/progression, except refractory disease
- •· ECOG > 2
- •· Age < 70 years
- •· Adequate contraception in female patients of child-bearing
- •· Written informed consent
- •· Availability of one of the following:
- •· A matched related or unrelated donor (MRD or MUD)
- •· A mismatched related donor (MMRD) sharing at least one full
- •haplotype (MMRD)
- •· An unrelated donor satisfying the minimum criteria of a 5/6
- •antigen match at HLA-A, -B and -DRB1 (MMUD)
- •· A single cord blood unit (CBU) with a cellularity as follows:
- •6/6 TNC > 3x10e7/kg*
- •5/6 TNC > 4x10e7/kg*
- •4/6 TNC > 5x10e7/kg*
- •· If a single CBU doesn’t reach the target dose, then two CBUs are
- •* This values are intented at the moment of collection.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 34
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •1. A hematopoietic cell transplantation-specific comorbidity index
- •(Sorror et al Appendix B) > 4
- •2. Active non-controlled infectious disease at the moment of inclusion
- •3. Active HBV or HCV infection
- •4. Impaired liver function (Bilirubin > 2.0 x upper normal limit;
- •Transaminases > 3.0 x upper normal limit)
- •5. Impaired renal function (Creatinine-clearance < 60 ml/min; Serum
- •Creatinine > 1.5 x upper normal limit).
- •6. Pleural effusion or ascites > 1.0 L
- •7. Pregnancy or lactation
- •8. Known hypersensitivity to treosulfan and/or fludarabine and/or
- •9. Non-co-operative behaviour or non-compliance
- •10. Psychiatric diseases or conditions that might impair the ability to give
- •informed consent
研究者
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