EUCTR2007-001286-15-IT进行中（未招募）1 期
Homoharringtonine (Omacetaxine Mepesuccinate; OMA) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) Who have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy - CGX-635-CML-203
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Male or female patients, age 18 years or older 2. Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase following TKI therapy. Patients with underlying disease phase of either accelerated or blast phase who enter the study with normalized blood counts due to hydroxyurea use will be enrolled into the study based on their actual disease phase (accelerated or blast). a) Patients in accelerated phase will meet one or more of the following criteria: ≥15% - <30% blasts in peripheral blood or bone marrow, ≥30% blasts + promyelocytes in peripheral blood or bone marrow, ≥20% basophils in peripheral blood or bone marrow; platelet count <100 x 109/L unrelated to therapy or clonal evolution. b) CML in blast phase will be defined as ≥30% blasts in the peripheral blood or bone marrow or presence of extramedullary disease other than spleen or liver. c) All other patients will be considered to have chronic phase CML 3. Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two TKIs. Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response). TKI treatment failure will be defined as one of the following: a) No complete hematologic response (CHR) by 12 weeks (whether lost or never achieved) b) No cytogenetic response by 24 weeks (i.e., 100% Ph-positive) (whether lost or never achieved) c) No major cytogenetic response by 52 weeks (i.e., ≥35% Ph positive) (whether lost or never achieved). d) Progressive leukocytosis: i) Increasing white blood cell count on at least two consecutive evaluations, at least 2 weeks apart and doubling from the nadir to ≥20,000/μL or ii) Absolute increase in WBC by ≥50,000/μL above the posttreatment nadir Intolerance to TKI therapy will be defined as one of the following: a) Grade 3-4 non-hematologic toxicity that does not resolve with adequate intervention b) Grade 4 hematologic toxicity lasting more than 7 days c) Any Grade ≥2 toxicity that is unacceptable to the patient 4. Patients must have completed all previous anti-leukemic therapy for at least 2 weeks prior to the first planned dose of OMA, except as noted below, and must have fully recovered from side effects of a previous therapy, unless disease progression necessitates early
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure. 2. Myocardial infarction in the previous 12 weeks. 3. Other concurrent illness which would preclude study conduct and assessment, including but not limited to another active malignancy (excluding squamous or basal cell skin cancer and in situ cervical cancer), uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not. 4. Pregnant or lactating. 5. Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol. 6. Lymphoid Ph+ blast crisis 7. Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent Patients excluded for any of the aforementioned reasons may be rescreened for participation at any time if the exclusion characteristic has changed, or is likely to change, and after consultation with the Principal Investigator and the Sponsor.
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