ACTRN12610000405011终止1 期
Phase 1 study investigating the safety and tolerability of RAD001 (Everolimus) in combination with chemotherapy for treatment of relapsed adult acute lymphoblastic leukemia (ALL)
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 20 人开始时间: 2010年5月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Morphologically and immunophenotypically confirmed diagnosis of precursor B ALL, negative for Philadelphia chromosome/ bcr-abl fusion transcripts, in first or subsequent relapse more than 6 months after starting treatment with a standard combination chemotherapy protocol.
- •Has provided written informed consent
- •Must be surgically sterile or female and postmenopausal (ie >12 mths since the last menstrual cycle) or, if capable of parenting a child, must be using medically acceptable and adequate method of contraception while undergoing protocol treatment and until 90 days after the last treatment.
- •Adequate renal, hepatic and cardiac functions at Screening as defined by:
- •Serum bilirubin <2.5 x upper limit of normal (ULN)
- •Serum creatinine < 1.5ULN, unless medically correctable
- •Adequate cardiac function with left ventricular ejection fraction (LVEF) >40% and no major left ventricular dysfunction
- •An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less at Screening
排除标准
- •Patients with other immunophenotypic variants of ALL (precursor T, mature B)
- •Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
- •Patients who have relapsed after an allogeneic transplant
- •Systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment
- •Radiotherapy within 14 days of commencing study treatment.
- •Prior therapy with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
- •Uncontrolled diabetes mellitus
- •CYP3A4 enzyme inducing anti-convulsant medication (eg phenytoin, phenobarbital, or carbemazepine), rifampin and rifabutin, and St. John’s Wort less than or equal to 14 days prior to study treatment
- •Ketoconazole less than or equal to 7 days before study treatment (Note: interaction with topical ketoconazole cannot be excluded).
- •Known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- •Unresolved toxicities from prior systemic therapy or radiotherapy that, in the opinion of the investigator, does not qualify the patient for study treatment.
- •Patients with known interstitial lung disease or severely impaired lung function (spirometry and diffusional capacity lung carbon monoxide (DLCO) 50% or less of normal and oxygen saturation of 88% or less at rest on room air).
- •Patients who have a history of another primary malignant disease, apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse.
- •Any uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as common terminology criteria (CTC) grade 2)
- •Chronic treatment with immunosuppressives
- •Patients who, in the opinion of the Investigator, have any severe and/or uncontrolled medical conditions or infections that may compromise study data
- •Untreated or symptomatic Central Nervous System (CNS) leukaemia
- •Previous adverse reaction to trial drug(s)
- •Patients with a known history of Human Immunodeficiency Virus (HIV) seropositivity
- •Uncontrolled Hepatitis B or C infection. Patients positive for Hepatitis B Virus (HBV) (Hepatitis B surface antigen (HBs Ag) that is not due to vaccination, or HBV deoxyribonucleic acid (DNA)) should undergo prophylactic antiviral therapy for 2 weeks prior to the first dose of RAD001, and for 4 weeks following the last dose of RAD001.
- •Participation in other therapeutic studies in the last 30 days except for studies with a non-medical intervention. Documented evidence of receiving placebo will be required.
- •Unable to receive treatment at an affiliated Australasian Leukaemia and Lymphoma Group (ALLG) centre
- •Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
研究者
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