NCT01221376Unknown2 期
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
Renato Melaragno1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the complete cytogenetic response with continuous-use of Imatinib.
研究概览
简要总结
The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase [LAP]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase.
- •Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used. Pregnant women won't be included.
- •Karnofsky and Lansky scale: ≥
- •Life expectation > 8 weeks.
- •Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP < 3 x ULN and albumin > 2 g/dl.
- •CNS toxicity ≤ II
- •Cardiac function: normal ejection fraction.
- •Signed ICF by child legal responsible.
排除标准
- •Patient receiving any other tyrosine kinase inhibitor (TKI).
- •Pregnant patient or breastfeeding.
- •Patient considered incapable to follow purposed treatment.
- •Patients with molecular relapsed.
- •Medications:
- •Colony stimulating: it cannot be administered at least 1 week before treatment.
- •Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines.
- •Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets <
- •INF-Α 48h before D
- •Hydroxyurea 24h before D
- •ARA-C doses >100 mg/m2 for 5-7 days, 14 days before D
- •Anthracyclines, Mitoxantrone or Etoposide 21 days before D
- •Any other chemotherapeutic agent 28 days before D
- •Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.
研究组 & 干预措施
Imatinib Mesylate
Experimental
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
Evaluate the complete cytogenetic response with continuous-use of Imatinib.
时间窗: Up to 12 months
次要结局
- Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+.(Up to 24 months)
研究者
Renato Melaragno
MD
Hospital Santa Marcelina
研究点 (1)
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