Etude Exploratoire randomisée Comparant le Traitement Par Gemtuzumab Ozogamicin /Cytarabine au Traitement Standard Par Idarubicine/Cytarabinechez Les Sujets âgés de 60 à 80 Ans et présentant Une LAM et un Caryotype Non défavorable
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 21
- 主要终点
- EFS (defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death)
研究概览
简要总结
Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged >60 years.
Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a morphologically proven diagnosis AML and both the following criteria:
- •Age ≥ 60 years and < 80 years.
- •Not previously treated for their disease.
- •With favourable or intermediate-risk cytogenetics. (Patients with urgent clinical need to begin treatment might be included before cytogenetic results, when necessary if they do not respond to Hydroxyurea. Patients might be included if the cytogenetic results are not expected in a time limit < 5 days after AML diagnosis).
- •Fit to receive intensive chemotherapy
- •Cardiac function determined by radionucleide or echography within normal limits.
- •Signed informed consent
排除标准
- •Presence of adverse cytogenetics (according to European LeukemiaNet recommendation.) (17) defined as one of the following abnormalities: -5/5q-, -7, t(6;9), t(v;11q23) excluding t(9;11), inv(3)(q21;q26.2) or t(3;3)(q21;q26.2), complex karyotype (3+ abnormalities)
- •Secondary AML following treatment with radiotherapy or chemotherapy.
- •AML following previously known myeloproliferative or myelodysplastic syndrome.
- •ECOG performance status (PS) 0 to 3
- •Serum creatinin level > or = 2.5N; AST and ALT level > or = 2.5N; total bilirubin level > or = 2N
研究组 & 干预措施
Mylotarg Arm
After randomization patients in the experimental arm are assigned to receive chemotherapy with:
Gemtuzumab Ozogamicin 3 mg/m2 (maximum dose: 5 mg) per IV, 60mn on Day 1 and 4 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7
干预措施: Gemtuzumab ozogamicin (GO) (Drug)
结局指标
主要结局
EFS (defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death)
时间窗: 5 years
Endoint for the primary objective of efficacy is EFS defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death.
次要结局
- Composite measure for safety(5 years)
- Composite measure for Efficacy assessed by CR/Cri rates, cumulative incidence of relapse, overall survival.(5 years)
研究者
Ms Juliette LAMBERT
Clinical coordinator
Versailles Hospital