NCT01809392Unknown2 期
Decitabine Augments for Post Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To assess the effects of decitabine on graft versus leukemia post transplant.
研究概览
简要总结
Allo - hematopoietic stem cell transplantation is currently the only way to cure myelodysplastic syndrome /acute leukemia . The existing experimental results showed that decitabine and 5-azacytidine up-regulated the expression of tumor Ags on leukemic blasts in vitro and expanded the numbers of immunomodulatory T regulatory cells in animal models. Reasoning that decitabine might selectively augment a graft versus leukemia effect, the investigators used decitabine administration after allogeneic stem cell transplantation to studied the immunologic sequelae.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Histologically confirmed AML in complete or partial remission or MDS using WHO classification undergoing alloHSCT
- •High resolution typing HLA-matched related or unrelated donor. Donors may be mismatched at single antigen at HLA-A, -B or -DR locus plus possible single antigen mismatch at HLA-C according to institution guidelines. Two-antigen mismatch at a single locus is not allowed.
- •creatinine < 1.5 times the institutional ULN or creatinine clearance (calculated by the Cockroft and Gault method) ≥ 30 mL/min
- •bilirubin < 1.5 times the institutional ULN
- •AST, ALT and alkaline phosphatase < 2.5 times the institutional ULN.
排除标准
- •History of previous alloHSCT prior to the current alloHSCT.
- •Persistent AML or MDS after alloHSCT.
- •Positive serology for HIV.
- •Pregnancy or nursing.
- •Other cancers less than or equal to 2 years prior study entry except: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer stage T1a or T1b.
- •Uncontrolled active infections requiring intravenous antibiotics. Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which, in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate protocol therapy.
- •Known or suspected hypersensitivity to decitabine.
- •Patients may not be receiving any other investigational agents.
- •General or specific changes in patient's condition that render the patient unacceptable for further treatment in judgment of the investigators.
研究组 & 干预措施
decitabine
Experimental
36 mg/m2 on day 42 after transplantation and administered daily for 5 consecutive days every 28 days for up to a total of 10 cycles
干预措施: decitabine (Drug)
结局指标
主要结局
To assess the effects of decitabine on graft versus leukemia post transplant.
时间窗: three years
次要结局
- To assess immunologic reconstitution after allo HSCT(three years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell TransplantationHigher-risk Myelodysplastic SyndromeRelapsed /Refractory Acute Myeloid LeukemiaNCT01806116The First Affiliated Hospital of Soochow University30
终止
2 期
Study of Decitabine Induction Prior to Allogeneic Hematopoietic Cell Transplant in Newly Diagnosed MDS PatientsMyelodysplastic SyndromeNCT01333449Singapore General Hospital6
Unknown
3 期
Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsLeukemiaNCT00043134European Organisation for Research and Treatment of Cancer - EORTC220
Unknown
不适用
Modified Post-Transplant Cyclophosphamide Regimen for Children With Juvenile Myelomonocytic LeukemiaHematopoietic System--CancerNCT03687463Capital Research Institute of Pediatrics6
已完成
不适用
Effect of 2nd Gen TKI in CMLMyeloid Leukemia, ChronicNCT02222272European Society for Blood and Marrow Transplantation432