EUCTR2013-000077-68-DE进行中（未招募）1 期
Imatinib continuation versus Nilotinib 300 mg twice daily in patients with chronic myeloid leukemia (CML) in chronic phase and major molecular response (MMR) without molecular response = 4.5 log (MR4.5) receiving Imatinib at a dose of 400 to 800 mg daily. An open-label, randomised multicenter phase 3b study to determine the confirmed rate of molecular response = 4 log (MR4) at two years - DECLINE
Medical Center - University of Freiburg0 个研究点目标入组 132 人开始时间: 2013年6月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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 written informed consent
- •2. Male or female patients aged =18 years (without upper limit of age)
- •3. ECOG performance status of 0 to 2
- •4. CML in chronic phase, with chronic phase defined as blasts < 15% in blood and/or bone marrow and peripheral blood basophils < 20% and platelets = 100 G/L
- •5. Pretreatment with Imatinib with a treatment duration of at least 18 months at a dosage of 400 to 800 mg daily
- •6. Major molecular response (MMR) without molecular response = 4.5 log (MR4.5), i.e. BCR-ABL>0.0032% and =0.1% IS confirmed by central laboratory at screen-ing will be required for randomisation
- •7. Patients must have a serum Creatinine of = 1.5 x ULN, SGOT = 1.5 x ULN, total bilirubin = 1.5 x ULN (except known M. Gilbert), and Lipase = 1.5 x ULN
- •8. Women of child-bearing potential defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months, must have a negative serum pregnancy test during screening period. Male and female patients of reproductive potential must agree to employ highly effective methods of birth control throughout the study and for up to 3 months following discontinuation of study drug. Appropriate methods are e.g. a highly effective method of first choice, i.e. a method with a low failure rate (less than 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectable, some Intra Uterine Devices (IUDs), vasectomized partner, in combination with a method of second choice like condom, diaphragm, or cup pessary with spermicidal foam/gel/film/cream/suppository.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Any previous treatment for CML other than Hydroxyurea, Imatinib or Interferon alpha
- •2. Evidence of features of accelerated or blast phase at any time (by European Leu-kemia Net; at least one crit.)
- •Accelerated phase:
- •o Blasts in blood or marrow 15-29%, or blasts plus promyelocytes in blood or marrow >30% with blasts <30%
- •o Basophils in blood =20%
- •o Persistent thrombocytopenia (<100 × 109/L) unrelated to therapy
- •o Clonal chromosome abnormalities in Ph+ cells (CCA/Ph+), major route, on treatment
- •Blast phase
- •o Blasts in blood or marrow =30%
- •o Extramedullary blast proliferation, apart from spleen
- •3. Previous loss of hematologic or cytogenetic response
- •4. Concomitant medications known to be strong inducers or inhibitors of P450 Iso-enzyme CYP3A4 (see Cytochrome P450 Drug Interaction Table under www.drug-interactions.com)
- •5. Finding of a secondary BCR-ABL resistance mutation at any time
- •6. History of intolerance to Imatinib that required treatment interruption longer than 4 weeks (cumulative) or dose reductions to less than 400 mg daily for longer than 4 weeks (cumulative) during the last 12 months before informed consent
- •7. Patients who had prior allogeneic, syngeneic or autologous bone marrow trans-plant or stem cell transplant
- •8. Patients unwilling to or unable to comply with the planned therapeutic intervention or to comply with the study treatment visits including blood sample collection with-in the protocol
- •9. History of pancreatitis, chronic inflammatory diseases or autoimmune diseases
- •10.Patients who underwent solid organ transplantation
- •11.Impaired cardiac function, including any of the following:
- •History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemi block, bifascicular block in screening ECG
- •Use of a cardiac pacemaker
- •ST depression of > 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads in screening ECG
- •Congenital long QT syndrome
- •QTc> 450 msec in the screening ECG
- •QT prolonging concomitant medication
- •History of or presence of significant ventricular or atrial tachyarrhythmia in screening ECG
- •History of or presence of clinically significant resting bradycardia (< 50 beats per minute)
- •Myocardial infarction within 12 months prior to informed consent
- •Unstable angina diagnosed or treated during the past 12 months before in-formed consent
- •Other clinically significant heart disease (e.g., congestive heart failure, uncon-trolled hypertension, history of labile hypertension)
- •12.Known HIV and/or hepatitis B or C infection (testing is not mandatory)
- •13.Other malignancies within the past 3 years before informed consent except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin
- •14.Women who are pregnant or breast feeding
- •15.Male/female patients of reproductive potential unwilling to practice a highly effec-tive method of birth control
- •16.History of noncompliance to medical regimens
- •17.Treatment with another investigational product during this study or during the last 30 days prior to informed consent
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