NCT01198054终止4 期
PILOT STUDY PHASE II, Multicenter, Non-randomized, TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN INDUCTION AND POST-INDUCTION IN PATIENTS WITH NOVO Acute Myeloid Leukemia (AML) WITH Cytogenetic Abnormality Monosomy 5
PETHEMA Foundation12 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 12
- 主要终点
- Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission.
At the same time, the study evaluate the security of lenalidomide.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirm the diagnosis of AML according to WHO criteria (Annex 4).
- •AML de novo (ie, patients without documented history of previous treatment with antineoplastic agents for radiotherapy or other oncological diseases, hematological or immunological, related to the development of secondary LMAs and secondary AML patients without primary MDS with del (5q) or -5 [documented history of primary MDS with transformation to LMAs]).
- •Diagnostic confirmation of the abnormality del (5q) or -5, with or without other cytogenetic abnormalities. It is not necessary that the del (5q) including band 5q
- •Patients who have received one cycle of induction chemotherapy consisting of a classical combination of anthracycline and cytarabine (with or without etoposide as a third agent associated), regardless of the response.
- •Patients have been evaluated the response to induction chemotherapy with anthracyclines and cytarabine (with or without etoposide as third agent partner) and were classified according to the criteria of IWG.20
- •≤ 60 patients ineligible for allogeneic hematopoietic progenitors.
- •Patients> 60 years are not eligible for allogeneic hematopoietic stem cell, or eligible but did not have HLA-identical brother.
- •Accept the use of any contraceptive method effective in patients of childbearing age with reproductive potential (see Section 6.5 on pregnancy prevention plan).
- •Ability to understand and voluntarily sign informed consent form.
- •Age ≥ 18 years at the time of signing the informed consent form.
- •Ability and willingness to follow the schedule of study visits.
排除标准
- •AML secondary to treatment with cytostatic or immunosuppressive agents, myelodysplastic syndrome or other neoplastic disease.
- •AML with cytogenetic abnormalities t (15, 17), t (8; 21), t (16; 16) or inv (16) or their associated molecular rearrangements.
- •Patients who have received remission induction with a different regime to cytarabine anthracycline / - etoposide.
- •≤ 60 patients eligible for allogeneic hematopoietic progenitors.
- •Patients> 60 years eligible for allogeneic hematopoietic stem cell transplant and who have HLA-identical brother.
- •Patients who have not been evaluated the response to induction chemotherapy (complete remission, partial remission or resistance (see Table 6).
- •Any of the following laboratory abnormalities Serum creatinine> 2.0 mg / dl (177 mmol / l). serum aspartate aminotransferase (AST) / glutamic oxalacetic transaminase serum (SGOT) or alanine aminotransferase (ALT) / serum glutamate pyruvate transaminase (SGPT)> 5.0 x upper limit of normal (ULN).
- •total serum bilirubin> 3 mg / dl.
- •Patient with known positive HIV serology. No HIV test is required in the process of selection.
- •Any severe psychiatric condition or disease that prevents the patient sign the informed consent form for the patient or involves an unacceptable risk should participate in the study.
- •Any serious organic disease or condition that behave for the patient if an unacceptable risk to participate in the study.
- •Previous use of cytotoxic chemotherapy agents or experimental agents (agents are not commercially available) for the treatment of AML.
- •Pregnant or breastfeeding (see Section 6.5 on pregnancy prevention plan).
研究组 & 干预措施
Lenalidomine
Experimental
Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5)
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy
时间窗: 12 months
Evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained reponse treatment (total resistance) or partial remission.
次要结局
- Safety and tolerability: Type and intensity of adverse events related with lenalidomide(1 year)
研究者
研究点 (12)
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