NCT01455025终止1 期
A Phase 1, Dose Escalation Study of Plerixafor in Combination With Induction and Consolidation Chemotherapy in Patients With Relapsed Acute Myeloid Leukemia
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- maximal tolerated dose
研究概览
简要总结
This is a phase 1, dose escalation study of Plerixafor in combination with granulocyte-colony stimulating factor , Daunorubicin and Cytarabine in adults patients with relapsed acute myeloid leukemia .
详细描述
The Primary objective is to determine the maximal tolerated dose and Recommended Phase 2 Dose of plerixafor when used in combination with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine during induction therapy Then determine the tolerability of plerixafor administered in combination with G-CSF and cytarabine during consolidation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Acute Myeloid Leukemia in first relapse with first response duration > 9 months.
- •Age between 18 and 65 years.
- •Treatment with hydroxyurea or purinethol is allowed if discontinued at least 24 hours before the start of study treatment.
- •White blood count less than 30 x 109/L
- •Left ventricular ejection fraction more than 50% on echocardiography or multigated acquisition scan or similar radionuclide angiographic scan.
- •Total bilirubin less than 1.5 x upper limit of normal= ULN or AST and ALT less than 2.5 x ULN or gammaGT less than 2.5 x ULN.
- •Serum creatinine less than 1.5 x ULN and/or creatinine clearance more than 50 ml/mn.
- •ECOG performance status less than 2
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Absence of pregnancy or lactation
- •Affiliated to French social security system or similar
- •Signed informed consent
排除标准
- •AML evolving from MPD and/or secondary AML
- •Patients treated with more than 270 mg/m2 of daunorubicin during first line therapy.
- •Have any of the following within the last 9 months :
- •Unstable supraventricular arrhythmia or patient with a pace-maker
- •Any ventricular arrhythmia
- •Congestive heart failure
- •Myocardial infarction, ischemia, stable coronary disease or angina pectoris
- •Syncope with a known cardiovascular etiology
- •Known hypersensitivity or contra-indication to drugs used in the protocol = G-CSF, daunorubicin, cytarabine or to excipients.
- •Previous treatment with plerixafor.
- •Previous hematopoietic stem cell transplantation = Allologous or autologous.
- •White blood count more than 30 x 109/L despite treatment with hydroxyurea or purinethol.
- •Treatment with chemotherapy or G-CSF within 3 months of screening.
- •Uncontrolled active infection.
- •Uncontrolled arrythmia
- •Grade more than 3 renal dysfunction with serum creatinine more than 1.5 x ULN and/or creatinine clearance less than 50 ml/mn.
- •Significant neurologic grade more than 2 or psychiatric disorder, dementia or seizures.
- •Clinical symptoms suggesting active central nervous system leukemia.
- •Pre-existing disorder predisposing the patient to serious or life-threatening infections = cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder or cytopenia
- •Thrombocytopenia refractory to platelet transfusion
- •Anticoagulant therapy
- •Severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock or disseminated intravascular coagulation.
- •Thrombocytopenia refractory to platelet transfusion.
- •Prior total body irradiation more than 10 Gy.
- •Known HIV, Hepatitis B or C positivity.
- •Participation into a clinical study of an investigational agent within 14 days before study entry.
- •Pregnancy or breastfeeding
- •Adult patient protected by law
- •Concurrent treatment with any other anti-cancer therapy except hydroxyurea
研究组 & 干预措施
Plerixafor granulocyte-colony stimulating factor
Experimental
4 steps of plerixafor doses from 240 to 480 microgram/kg per day concomitant with GCSF and chemotherapy 3 to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.
干预措施: Plerixafor granulocyte-colony stimulating factor (Drug)
结局指标
主要结局
maximal tolerated dose
时间窗: 40 days
4 steps of plerixafor doses from 240 to 480 microgram per kilogram per day concomitant with granulocyte-colony stimulating factor and chemotherapy Three to 6 evaluable patients will be enrolled at each dose level in a modified 3 + 3 design.
次要结局
- Efficacy of plerixafor on leukemic blasts(10 Days)
- Efficacy of combination plerixafor with granulocyte-colony stimulating factor, Daunorubicin and Cytarabine(9 months)
- safety and tolerability of plerixafor in combination with granulocyte-colony stimulating factor and chemotherapy(9 months)
研究者
研究点 (1)
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