NCT00612274已完成早期 1 期
Pilot Study of Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute Graft Versus Host Disease in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety/Efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate
研究概览
简要总结
The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have an identified 8/10 or 9/10 matched unrelated donor identified following a formal search with confirmatory typing through the national marrow donor program as the best available donor. No matched sibling or fully matched unrelated donor has been identified. HLA typing of donor and recipient will be performed by high resolution molecular typing at HLA A, B, C and DRB1/DQ loci. Patients whose best available donor is matched at 8/10 loci must have at least one of the mismatches at the DQ locus. (no more than one mismatch at HLA A,B,C,DR allowed).
- •Candidates for this trial will meet the following criteria:
- •Adequate organ function for conditioning type:
- •For patients receiving ablative conditioning
- •Left Ventricular ejection fraction >45%
- •DLCO >50%
- •Creatinine <1.5
- •Hepatic enzymes <3x upper limit of normal.
- •KPS >70%
- •For patients receiving non-ablative conditioning:
- •KPS >70%
- •Patients with the following diseases will be considered eligible:
- •AML in first remission with high risk features (poor risk cytogenetic abnormalities9, persistent elevated blast count on day +15 or recovery marrow after induction therapy).
- •AML beyond first remission
- •ALL in first remission with high risk features (ph+, t4:11)
- •ALL beyond first remission
- •High risk Myelodysplasia (RAEB-II, RAEB-I with poor-risk cytogenetics)
- •Recurrent Aggressive Non-Hodgkins or Hodgkins lymphoma (indolent histologies excluded) who have failed autologous transplant or have had inadequate response to salvage therapy.
- •CML with transformation
- •CLL with transformation or Fludarabine failure.
- •Severe aplastic anemia with recurrence or failure after immunosuppressive therapy.
排除标准
- •Prior allogeneic transplantation
- •Active CNS leukemia.
- •Female patients who are pregnant or breast feeding
- •Karnofsky performance status <70%.
- •Active viral, bacterial or fungal infection.
- •Patients seropositive for HIV -1,2; HTLV -1,2 (due to the additional immunodeficiency induced by transplantation and immunosuppressive therapy) Requirement for antifungal prophylaxis with Voriconazole for the first 30 days is prohibited.
- •Patients not providing informed consent.
研究组 & 干预措施
1
Experimental
sirolimus, tacrolimus and short course methotrexate
干预措施: tacrolimus (Drug)
1
Experimental
sirolimus, tacrolimus and short course methotrexate
干预措施: Sirolimus (Drug)
1
Experimental
sirolimus, tacrolimus and short course methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
Safety/Efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate
时间窗: Upon completion of study
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
Sirolimus for Improving Social Abilities in People With PTEN Germline MutationsPTEN Gene MutationPTEN Hamartoma Tumor SyndromePTEN Hamartoma SyndromeNCT06080165Stanford University
Unknown
2 期
A Pilot-Study of Sirolimus for the Treatment of Systemic SclerosisSystemic SclerosisNCT03365869Peking University People's Hospital72
已完成
不适用
The ILLUMINA Study. (ILLUMINA)Peripheral Arterial DiseaseNCT03510676CID - Carbostent & Implantable Devices100
已完成
4 期
Pilot Study on the Use of Sirolimus to Treat Chronic Allograft Nephropathy in Children After Kidney TransplantKidney TransplantationNCT00188955University of Manitoba40
进行中（未招募）
1 期
Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced CancerAdvanced CancerNCT01087554M.D. Anderson Cancer Center249