EUCTR2007-004252-37-FR进行中（未招募）不适用
A Phase I/II open label study to assess efficacy and safety of IPH1101 associated with low dose of interleukin 2, as add-on therapy to imatinib in CML patients with residual molecular disease
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Signed informed consent prior to any protocol-specific procedures
- •2) BCR-ABL positive CML treated with first line imatinib as follow:
- •At least 2 years of treatment with imatinib,
- •At least 3 months since any imatinib dosage modification,
- •3) Complete cytogenetic response ((CCR) confirmed by recent cytogenetic analysis < 6 months)
- •4) Bcr-Abl/Abl ratio measured by qRT-PCR in blood (according to the european recommendations) between = 1% and > 0,001% within 3 months prior to inclusion.
- •5) Dosage of imatinib at screening and pre-inclusion within the range 800ng/ml – 1800ng/ml
- •6) Aged over 18 years
- •7) Adequate bone marrow, hepatic and renal function as follows:
- •- Lymphocytes > or = 900/µl
- •- Platelets > or =100 x 10E9/l,
- •- Total bilirubin < or = 2 x upper limit normal (ULN)
- •- Transaminases (AST [SGOT]; ALT SGPT]) < ou = 3 x ULN
- •- Serum creatinine < or = 2 x ULN
- •8) Normal thyroid function ( 0,15< TSH<5mU/l)
- •9) QTc interval duration < 430 ms for men, < 450 ms for women
- •10) At least 2 weeks since previous surgery
- •11) Male or female patient who accepts and is able to use recognised highly effective contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pregnant or lactating women
- •2) Concurrent treatment with any other anti-cancer therapy or any forbidden concomitant treatments:
- •- Biphosphonates and immunosuppressive agents,
- •- Systemic and chronic inhaled steroids,
- •- Beta-blockers and calcium channel blockers
- •3) Participation in another clinical trial with any investigative drug within 30 days prior to study randomisation
- •4) Prior history of high dose chemotherapy followed by bone marrow or peripheral stem cell support or presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to study inclusion)
- •5) Any known hypersensitivity to one of the study treatments
- •6. Current active infection
- •7) Serious concurrent uncontrolled medical disorder such as diabetes, autoimmune disease,
- •8) Severe viral infection HIV, HCV, HBV (HBsAg)
- •9) Cardiovascular disease:
- •- Stage III or IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure. Note: patients with NYHA stage I or II CHF may be included provided they do not have arrythmia requiring treatment or fulfil any other exclusion criteria,
- •- Myocardial infarction within the previous 6 months, or
- •- Symptomatic cardiac arrhythmia requiring treatment,
- •10) History of another malignancy within the past 5 years, except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
- •11) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before request for inclusionin the trial.
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