EUCTR2006-004517-17-FR进行中（未招募）不适用
A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (CGX-635) in the Treatment of Refractory or Relapsed Acute Myeloid Leukemia (AML)
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.Male or non-pregnant female patients, 18 years or older, diagnosed with refractory (no response to a previous combined chemotherapy including at least cytarabine + one anthracycline) or relapsed acute myeloid leukemia (AML)
- •2.Patients must not qualify for other alternative therapy of higher order. This restriction does not apply to other treatments such as hormonal therapy or biological response modifiers.
- •3.Patients must have completed all previous anti-leukemic therapy (except leukapheresis) for at least 2 weeks prior to first planned dose of HHT and must have fully recovered from side effects of a previous therapy, unless disease progression necessitates early therapy. In patients with rapidly proliferating disease, hydroxyurea may be administered prior and during the first 9-day HHT administration course, if clinically indicated, to control disease. Leukapheresis is allowed up to 24 hours prior to registration.
- •4.All medications necessary for the treatment of other chronic patient conditions should be administered at a stable, maintenance dose for 30 days prior to the first study drug administration and during the course of study treatment, except in circumstances where therapeutic agents are administered on a sliding scale based upon changes in body weight, hematology or serum chemistry, e.g. insulin for diabetes.
- •5.ECOG performance status 0-2.
- •6.Life expectancy greater than 4 weeks.
- •7.Patients able to comply with the requirements of the entire study.
- •8.Patients able and willing to provide written informed consent prior to any study related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)
- •9.Sexually active patients and their partners must use an effective double barrier method of contraception associated with a low failure rate (i.e., less than 1% per year) during and for six months after completion of study therapy. The following are considered effective contraceptives: (i) oral contraceptive pill, (ii) condom, (iii) diaphragm plus spermicide, (iv) abstinence, (v) patient or partner surgically sterile, (vi) patient or partner more than 2 years post-menopausal or (vii) injectable or implantable agent/device.
- •10.Patients must have health insurance or similar coverage
- •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.Patients with NYHA class III or IV heart disease, active ischemia or any uncontrolled, unstable cardiac condition for which treatment for the condition is indicated but is not controlled despite adequate therapy, including angina pectoris, cardiac arrhythmia, hypertension or congestive heart failure.
- •2.Patients who have experienced a myocardial infarction in the previous 12 weeks.
- •3.Patients with any 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, positive HIV status or positive HTLV I/II status, whether on treatment or not.
- •4.Patients with clinically significant Screening serum chemistry results which are not attributed to study disease, including but not limited to SGPT (ALT) >3 times the upper limit of normal, creatinine >2.0 mg/dl and bilirubin >2.0 mg/dl.
- •5.Patients who are pregnant or lactating.
- •6.Patients receiving systemic chemotherapy in the 2 weeks prior to the first study drug administration, unless treatment required for leukemia progression.
- •7.Patients with any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
- •8.Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent.
研究者
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