Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 48
- 主要终点
- Overall survival
研究概览
简要总结
QUESTIONS AND OBJECTIVES OF ALL-MB 2015 STUDY
- Will the new risk group stratification (especially of T-ALL) to improve overall and event-free survival?
- Will the new protocol is effective and feasible in patients older than 15 years, and especially in young adults?
- Whether the intermittent dexamethasone administration in induction will result in a decrease in toxicity and mortality without loss of efficacy?
- Whether the methylprednisolone administration as basic glucocorticoids during induction, consolidation and maintenance therapy will lead to decrease of severe infections and early mortality rate, improve survival and therapy compliance in adolescents and young adults with B-precursor ALL?
- Whether the administration of Bortezomib in patients with B-precursor ALL with initial WBC≥100,000/µl will improve treatment outcome?
- Whether the administration of Idarubicin instead Daunorubicin in low-risk T-ALL patients and two-phase induction in intermediate-risk T-ALL patients will reduce relapse rate and improve survival?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at diagnosis at 1 to 50 years.
- •The start of induction therapy within a time interval of study recruitment phase.
- •The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see "Diagnostics"). Patients with B-cell (Burkitt) ALL are excluded.
- •Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this multicenter study.
排除标准
- •ALL is a second malignancies;
- •The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;
- •There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);
- •There is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of ALL-AML (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible);
- •The patient was treated before for a long time with cytotoxic drugs;
- •There were treatment deviations not covered by the protocol and/or not due to side effects of treatment and/or complications of the disease
研究组 & 干预措施
Dexa intermittent
Induction therapy with intermittent Dexamethasone administration (1-15 days - 6 mg/m2, 15-22 day - pause, 22-29 days - 6 mg/m2).
干预措施: Dexamethasone intermittent (Drug)
Dexa constant
Induction therapy with continuous Dexamethasone administration (6 mg/m2 1-29 days).
干预措施: Dexamethasone continuous (Drug)
Dexa
Therapy with Dexamethasone (6 mg/m2) as basic glucocorticoid preparation.
干预措施: Dexamethasone (Drug)
Medrol
Therapy with Methylprednisolone (60 mg/m2) as basic glucocorticoid preparation.
干预措施: Methylprednisolone (Drug)
IDA
Induction and consolidation therapy with Idarubicin
干预措施: Idarubicin (Drug)
DNR
Induction and consolidation therapy with Daunorubicin
干预措施: Daunorubicin (Drug)
Protocol Ib+
Two-phase induction therapy (additional second phase of induction - protocol Ib)
干预措施: Second phase of induction (Drug)
Protocol Ib-
Standard induction therapy (without second phase)
干预措施: Standard induction therapy (Drug)
Bortezomib-
Consolidation therapy without Bortezomib
干预措施: Standard consolidation therapy (Drug)
Bortezomib+
Consolidation therapy with Bortezomib 1.3 mg/m2 N12 (N4 in each reinduction)
干预措施: Bortezomib (Drug)
结局指标
主要结局
Overall survival
时间窗: 3 years, 5 years and 10 years after study start
Event-free survival
时间窗: 3 years, 5 years and 10 years after study start
Cumulative incidence of relapse
时间窗: 3 years, 5 years and 10 years after study start
次要结局
- Remission death rate(3 years, 5 years and 10 years after study start)
- Early death rate(3 years, 5 years and 10 years after study start)
研究者
Karachunskiy Alexander
Deputy director - Director of Institute of Oncology, Radiology and Nuclear Medicine of Federal Research Institute of Pediatric hematology, Oncology and Immunology
Federal Research Institute of Pediatric Hematology, Oncology and Immunology