NCT00146913Unknown2 期
A Phase II Study Evaluating the Efficacy and Tolerance of Combination Therapy of Imatinib Mesylate (IM) +-2A Interféron for Chronic Phase CML Patients Resistant or Refractory to IM Used as Single Therapy for at Least One Year
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
研究概览
简要总结
Sixty % of CML patients treated by Imatinib mesylate achieved a major cytogenetic responses (CCR) at 18 months. So, 40% of the patients must receive additional treatment. In vitro, it has been shown that IM and Interféron-alpha have synergic anti-proliferative effect on chromosome Ph+ cell lines. By using Peg-Interféron and IM combination, we hope to increase the cytogenetic response of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic phase Philadelphia positive CML, confirmed by karyotyping (or FISH) analysis, in complete hematologic response with IM.
- •Lack of major cytogenetic response after at least one year of STI 571 as single therapy.
- •Male and female * 18 years old.
- •Informed consent signed up.
- •Performance status grade 0 - 2 (ECOG).
- •SGOT and SGPT <3N
- •Serum bilirubin < 1.5 N
- •Serum creatinine < 1.5 N
- •No HSC graft planned
- •B-HCG negative for female with potential childbearing
排除标准
- •Absence of complete hematologic response
- •Extramedullar involvement
- •Previous extra-hematologic intolerance of Interféron at a dose superior or equal to 25 MUI/week
- •Depressive syndrome not controlled
- •Not controlled dysthyroidy
- •Auto-immune pathology not controlled
- •Women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study
- •Significant cardiac disease (grade 3 or more)
- •Known seropositivity for HIV
- •Active viral hepatitis
- •Other malignant disease
- •Other experimental medication
结局指标
主要结局
Study the maintenance of a complete hematologic response, the cytogenetic and molecular responses, and the overall survival of the patients population
次要结局
- Evaluate the tolerance of a combination of STI571 and alpha-interferon
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular ResponseMyeloid Leukemia, ChronicNCT00210119Institut Bergonié19
终止
3 期
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular ResponseLeukemia, Myeloid, Chronic-PhaseNCT01827930Institut Bergonié68
已完成
2 期
A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CMLLeukemia, Myelogenous, Chronic, BCR-ABL PositiveNCT02896842Versailles Hospital139
Unknown
2 期
Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM StudyCML, Chronic PhaseNCT02949570Hybrigenics Corporation54
已完成
2 期
Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid LeukaemiaChronic Myeloid LeukaemiaNCT02001818Australasian Leukaemia and Lymphoma Group60