A Retrospective Study to Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia(ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
Although the response rate by first-line treatment has been improved, most adult patients with relapsed or refractory ALL will eventually relapse with poor outcomes regardless of treatments. To further understand current status of the treatment of adult patients with relapsed or refractory ALL in China, the study retrospectively collected diagnosis and treatment data from ALL patients in 14 centers in China. Primary objective: to estimate the proportion of patients in overall response rate (ORR) for early relapsed or primary refractory Philadelphia chromosome negative (Ph-) B-precursor ALL patients following salvage treatment (i.e., proportion of patients in hematological complete remission [CR] and CR with partial recovery of blood cells [CRh*]); Secondary objectives included: to estimate the proportion of patients in CR, CRh* and CRi(CR/CRh*/CRi) and the duration of CR/CRh*/CRi, overall survival, duration of CR/CRh*and the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment; Exploratory objectives included: to estimate the efficacy in late relapsed Ph- B-precursor ALL (first remission duration > 12 months) patients and in Ph+ B-precursor ALL patients and specific subgroup patients following salvage treatment.
详细描述
Title A Retrospective Study to Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients with Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (BLING)
Key Words Relapsed or refractory acute lymphoblastic leukemia, complete remission, duration of remission, overall survival, hematopoietic stem cell transplantation
Study Background and Rationale Although the response rate by first-line treatment has been improved, most adult patients with relapsed or refractory ALL will eventually relapse with poor outcome regardless of treatments. In order to improve the diagnosis and treatment level of adult ALL in China, Chinese Society of Hematology and Committee of Hematologic Malignancies of the Chinese Anti-Cancer Association released Expert Consensus on Diagnosis and Treatment of Acute Lymphoblastic Leukemia in Chinese Adult Patients in 2012. However, there is no nationwide multi-center retrospective observational study to evaluate the treatment status of adult patients with R/r ALL (including treatment regimens, and remission rate, overall survival and rate of allogeneic hematopoietic stem cell transplantation of R/r ALL patients following standard salvage chemotherapy), and these data will provide an important reference for further standardization of the treatment of ALL in China, improvement of the prognosis and the research and development of new drugs.
Study questions and Objectives
Primary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese adult patients with R/r B-precursor ALL who had received salvage treatment
- •At least one complete response evaluation results available for salvage treatment
- •With definite Ph chromosome status
- •Age ≥15 years at time of de novo (initial) diagnosis of ALL.
- •For relapsed patients who met the above conditions must also have
- •Evaluable duration of CR by initial therapy
- •No central nervous system involved at relapsed
- •No isolated extramedullary relapse Patients were divided into 3 analysis sets based on molecular genetic factor and type, and time from initial response to relapse.
- •Ph- Primary Analysis Set included patients who are diagnosed with Ph- disease and meet one of the following criteria:
- •in first relapse or salvage treatment after a first complete remission duration of ≤12 months, or refractory to initial treatment, or relapsed/refractory after first or subsequent salvage treatment, or Relapsed/refractory within 12 months after alloHSCT.
- •The Ph- Late Relapse Analysis Set included patients who had a first remission duration of >12 months and were in first relapse or salvage treatment.
- •The Ph+ Analysis Set included patients who were diagnosed with Ph+ disease.
排除标准
- 未提供
结局指标
主要结局
overall response rate
时间窗: up to 3 years
overall response rate after the last salvage therapy, i.e., CR/CRh\*. CR is generally defined as no blasts in peripheral blood, absence of extramedullary leukemia, full recovery of peripheral blood counts, ≤ 5% blasts in the bone marrow, ANC \> 1.0×109/L, PLT \> 100×109/L, no relapse within 4 weeks. CRh\* was CR with partial recovery of peripheral blood counts, ANC \> 0.5×109/L, PLT \> 50×109/L, with other conditions meeting the criteria for CR
次要结局
- proportion of patients in CR, CRh* or CRi(up to 3 years)
- overall survival(up to 3 years)
- duration of remission (CR/CRh*, CR/CRh*/CRi)(up to 3 years)
- proportion of patients receiving allogeneic hematopoietic stem cell transplantation(up to 3 years)
- duration of CR/CRh*/CRi(up to 3 years)
- the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT)(up to 3 years)
- Complete Response(up to 3 years)
- Complete Response with incomplete recovery of blood cells(up to 3 years)
- Complete Response with partial recovery of blood cells(up to 3 years)
- duration of CR/CRh*(up to 3 years)
研究者
Jun Ma
Chief physician of department of Hematology and Oncology
Harbin Hematology and Oncology Institute