NCT05190549已完成2 期
CAV Regimen (Cladribine Combined With Low Dose Ara-C and Venetoclax) Pretreatment Followed by Hematopoietic Stem Cell Transplantation for Relapsed or Refractory Acute Leukemia: a Multi-center, Open-label and Prospective Clinical Trial
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR (overall response rate)
研究概览
简要总结
Although allogeneic hematopoietic stem cell transplantation (HSCT) is a curative treatment option for acute leukemia (AL), relapsed or refractory (R/R) AL is still a big challenge. It is believed that decreased tumor burden before HSCT is a favorable factor contributing to the long-term survival of R/R AL patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before HSCT, there is still no consensus that which regimen is optimal. This study is to investigate the curative efficacy and safety of bridging CAV (cladribine combined with low dose Ara-C and venetoclax) regimens followed by HSCT treatment protocol for R/R AML.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AL must meet one of the following criteria ：A or B. A: relapsed AL disease was defined as follows: (1) Reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of >5% blasts in the bone marrow (BM) not attributable to another cause(e.g. regeneration after consolidation therapy); or (3) extramedullary relapse.
- •B: refractory AL disease was defined as follows: (1) failure to achieve CR, CRh or CRi after two courses of intensive induction treatment. or (2) failure to achieve complete remission after one cycle of induction chemotherapy or a reduction in the number of blasts of less than 50% after one cycle of induction treatment, with residual blasts >15%.
- •patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions.
- •sign informed consent voluntarily.
- •Patients aged between 16 and 70 years old, male or female is permitted.
- •ECOG performance status score less than
- •The expected survival is longer than 3 months.
排除标准
- •With other malignant tumors.
- •Patients received the treatment of cladribine or venetoclax.
- •Patients received cardiac angioplasty or stent implantation.
- •Active infections that are not under clinical control (bacteria or fungus or virus is included).
- •Liver functions abnormalities (total bilirubin>1.5 times the upper limit of the normal range, ALT/AST>2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST>1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine>1.5 times the upper limit of normal value).
- •Pregnant or nursing women.
- •Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
- •Patients participated in any other clinical trials 3 months prior to signing the informed consent.
- •Patients not suitable for the study according to the investigator's assessment.
结局指标
主要结局
ORR (overall response rate)
时间窗: 1 month
ORR was calculated as the sum of CR, CRi, MLFS and PR.
次要结局
- EFS (Event-free survival)(1 year)
- Adverse events (AEs)(2 months)
- OS (Overall survival)(1 year)
研究者
Sheng-Li Xue, MD
Prof.
The First Affiliated Hospital of Soochow University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaNCT03035422Association for Training, Education, and Research in Hematology, Immunology, and Transplantation24
已完成
不适用
Sequential Conditioning in Haploidentical Transplantation for Hematopoietic Stem Cells in Patients With Relapsed or Refractory Lymphoid Hematological DisordersRefractory or Relapsed Lymphoid HaemopathyNCT03079089Association for Training, Education, and Research in Hematology, Immunology, and Transplantation40
已完成
2 期
CLAGE Sequential With Flu-Bu Conditioning for Refractory Acute LeukemiaRefractory Hematologic CancerAllogeneic Stem Cell TransplantationNCT03882203Shanghai Jiao Tong University School of Medicine18
招募中
3 期
Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated DonorGVHDNCT06083129Assistance Publique - Hôpitaux de Paris324
已完成
2 期
Clofarabine Salvage Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)Acute Myeloid LeukemiaNCT01295307Technische Universität Dresden86