Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To determine the proportion of overall survival and disease-free survival
研究概览
简要总结
Acute lymphoblastic leukemia (ALL) is characterized by the abnormal proliferation of immature precursor cells, disrupting normal hematopoiesis and causing severe anemia and thrombocytopenia due to genetic mutations. Conventional treatment with intensive chemotherapy is limited for elderly patients or those with comorbidities, adversely affecting their survival. In Mexico, alongside a higher incidence, treatment-related complications are more frequent, particularly with drugs such as asparaginase or anthracyclines, which limits therapeutic efficacy. The transition to infusion-based therapies promises to reduce these complications, improve treatment tolerance, and optimize clinical outcomes, marking a significant advancement in the management of this disease. Modifying treatment regimens toward infusion therapies has the potential to significantly reduce adverse complications, enhance treatment tolerance, and ultimately improve clinical outcomes for patients who cannot benefit from conventional intensive regimens. This approach not only aims to optimize treatment effectiveness but also to minimize associated risks, thus representing an important advancement in the management of acute lymphoblastic leukemia in clinical settings such as those in Mexico
详细描述
The treatment of acute lymphoblastic leukemia (ALL) in adults represents a therapeutic challenge, particularly in patients with high-risk factors, clinical frailty, or socioeconomic limitations that hinder adherence to intensive outpatient regimens. While protocols such as HyperCVAD have been widely used, their toxicity can be significant in certain subgroups. In this context, the EPOCH regimen has been explored as an inpatient consolidation alternative that allows a gradual transition toward less toxic regimens, with potential benefits in vulnerable populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Diagnosed with acute lymphoblastic leukemia (ALL) according to the World Health Organization (WHO) criteria
- •Older than 18 years old
- •ECOG Performance Status Scale >1 or the Karnofsky Performance Status (KPS) <80%.
- •Comorbidities: diabetes mellitus, arterial hypertension, thrombotic events, endocrine disorders, or any condition that hinders the administration of full-dose chemotherapy.
- •Toxicity prior to a standard chemotherapy regimen.
- •Both genders
- •Over 18 years of age
- •No upper age limit
- •Signed informed consent
排除标准
- •´- Patients refractory to induction treatment
- •Patients who have previously received a low-intensity regimen due to comorbidities
- •Biphenotypic leukemia
- •CNS involvement at diagnosis requiring radiotherapy
- •Patients whose survival is expected to be less than 48 hours due to leukemiarelated complications
- •Patients with a history of ischemic or hemorrhagic stroke or severe neurological deterioration
- •Pregnant patients
研究组 & 干预措施
Frail ALL patients by ECOG >1 or KPS <80%, or with severe toxicity from induction therapy
Patients newly diagnosed with acute lymphoblastic leukemia (ALL) who are considered clinically frail based on an ECOG performance status score greater than 1 or a Karnofsky score below 80%, indicating a high risk of severe chemotherapy-related toxicity. This group also includes patients who have previously received induction therapy and experienced severe, limiting toxicity that prevents continuation of intensive treatment regimens. These criteria identify a vulnerable population for whom standard chemotherapy may not be suitable, necessitating alternative, less intensive treatment approaches to reduce toxicity while maintaining therapeutic efficacy
干预措施: Patients meeting criteria will receive DA-EPOCH via central line for 5 days every 21 days, with monitoring, supportive care, transfusions, prophylaxis, and G-CSF for 5 doses per cycle (Drug)
结局指标
主要结局
To determine the proportion of overall survival and disease-free survival
时间窗: From enrollment until 1 year after the end of treatment.
For the survival analysis, the Kaplan-Meier method will be used, which is a non-parametric technique employed to estimate the survival function from time-to-event data.
次要结局
- To determine the proportion of complete remissions (<5% blasts per field) after the first 4 weeks of induction therapy and the proportion of measurable residual disease (proportion of cells) at 6 weeks.(Complete Remision (CR) at 4 weeks after induction and measurable residual disease (MRD) at 6 weeks of treatment.)
- To establish the proportion of serious adverse events associated with the chemotherapy regimen.(From enrollment until 1 year after the end of treatment.)
- To describe the proportion of severe neutropenia events and treatment-related mortality(From enrollment until 1 year after the end of treatment.)
- To describe the length of hospital stay in days.(From hospital admission to the last day of stay for each administered cycle (each cycle is 21 days).)
研究者
Christian Omar Ramos-Peñafiel, MD, PhD
Medical Doctor, Principal Investigator, Clinical Professor
Hospital General de México Dr. Eduardo Liceaga