A Simplified Patient Care Strategy to Decrease Early Deaths in Acute Promyelocytic Leukemia (APL)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
- 试验地点
- 578
- 主要终点
- One-month Mortality Rate
研究概览
简要总结
This clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. Implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate if the proposed patient care strategy, that includes use of simplified guidelines along with acute promyelocytic leukemia (APL) expert support, decreases the one-month induction mortality rate from 30% to under 15%.
SECONDARY OBJECTIVES:
I. To assess the overall survival 1 year after accrual is completed. II. To assess incidence and severity of differentiation syndrome. III. To correlate outcomes with time to initiation of all-trans retinoic acid (ATRA) from diagnosis or suspicion of diagnosis.
IV. To compare outcomes between academic and community centers separately. V. To evaluate factors associated with outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed to have a diagnosis of APL, which is defined as:
- •Positive t(15:17) by fluorescence in situ hybridization (FISH) or conventional karyotype
- •Positive promyelocytic leukemia/retinoic acid receptor PML/RAR alpha by polymerase chain reaction (PCR)
- •Patients must accept treatment and supportive care guidelines
- •Referrals must be made as early as possible but no later than 5 calendar days after ATRA therapy is initiated; consent can be obtained up till day 7 or earlier
- •Co-management can be started as soon as referral is made including weekends; the physician at the outlying facility should make every effort to call the APL expert at the first suspicion of APL
排除标准
- 未提供
研究组 & 干预措施
Simplified Patient Care Strategy plus APL Expert Support
Patients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment.
干预措施: Simplified Patient Care Strategy (Other)
Simplified Patient Care Strategy plus APL Expert Support
Patients receive standard of care treatment for APL. Treating physicians regularly discuss with an APL expert to identify and mange treatment.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
One-month Mortality Rate
时间窗: Assessed at one month
Proportion of patients died within one month from the first date of induction therapy.
次要结局
- Survival Rate at One Year(Assessed at one year)
- One-month Survival Rate by Lead Academic Sites and Community Sites(Assessed at one month)
- Differentiation Syndrome Rate(Assessed up to 1 year)
- Association Between One-month Survival and Baseline Factors(Assessed at baseline and one month)
- Association Between One-month Mortality Rate and Time From Diagnosis to Initiation of All-trans Retinoic Acid (ATRA)(Assessed at one month)