A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 34
- 主要终点
- Complete remission rate after 2 phases of induction
研究概览
简要总结
The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.
详细描述
The study will
- establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;
- disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;
- establish national standards of care for this patient group;
- provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
- •Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
- •Willing and able to give consent
排除标准
- •Known HIV infection
- •Blast transformation of CML
- •Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
- •Women who are pregnant or lactating
研究组 & 干预措施
Philadelphia Positive Patients
All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
干预措施: Chemotherapy (Drug)
Philadelphia -ve Patients- Intensive
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
干预措施: Chemotherapy (Drug)
Philadelphia -ve Patients- Intensive +
Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group
干预措施: Chemotherapy (Drug)
Philadelphia -ve Patients- Non Intensive
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Complete remission rate after 2 phases of induction
时间窗: Approximately 2 months after start of treatment
All patients will be assessed for their remission status at the end of Phase 2 induction. The CR rate at this timepoint will then be calculated.
次要结局
- Duration of in-patient hospitalisation(Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance)
- Quality of life aspects assessed at diagnosis/baseline at various time points(Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance)
- Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.(At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment)
- Relationship between performance status/co-morbidity and treatment option chosen(At registration)
- Complete remission rate after 1 phase of induction(Approximately 1 month after start of treatment)
- Overall Survival at 1 year(1 year after registration)
- Tolerability of treatment as determined by occurrence of key adverse effects(Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment)