ISRCTN34386131已完成1 期
Phase I/II clinical trial to assess the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase (PARP) -inhibitor, in relapsed and refractory chronic lymphocytic leukaemia patients with an 11q deletion or ATM mutation and relapsed/refractory patients with T-prolymphocytic leukaemia and mantle cell lymphoma
niversity of Birmingham (UK)0 个研究点目标入组 15 人开始时间: 2010年2月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28643365 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Relapsed or refractory chronic lymphocytic leukaemia (CLL), mantle cell lymphoma or T-prolymphocytic leukaemia (T-PLL) patients (World Health Organization [WHO] Classification of Haematopoietic and Lymphoid Tissues, Fourth Edition) who are not considered to be appropriate for further conventional treatment
- •2. CLL patients only: confirmation of chromosome 11q deletion by fluorescent in situ hybridisation (FISH) or an ATM mutation (ATM mutation requires the presence of both a predicted ATM mutation and demonstration of reduced ATM dependent phosphorylation)*
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- •4. Aged 18 years or older, either sex
- •5. Written informed consent
- •6. Not known to be positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen and hepatitis C antibody
- •7. Estimated life expectancy of greater than 16 weeks
- •*Please note that confirmation of 11q deletion or an ATM mutation prior to registration is not required for CLL patients taking part in phase 1 (dose escalation phase). All other eligibility criteria apply to both phase 1 and phase 2.
排除标准
- •1. Receiving treatment for CLL, mantle cell lymphoma or T-PLL including corticosteroids (greater than 10 mg prednisone/day or equivalent) or have received treatment for CLL, mantle cell lymphoma or T-PLL for the 4 weeks prior to study entry
- •2. Receiving corticosteroids (at a dose greater than 10 mg prednisone/day or equivalent) for other medical conditions
- •3. Previous treatment with a PARP-inhibitor, including olaparib
- •4. A known hypersensitivity to olaparib or any excipient of the product
- •5. Treatment with any investigational product within 28 days of registration
- •6. Receiving or have received the following inhibitors of CYP34A:
- •6.1. Azole antifungals
- •6.2. Macrolide antibiotics
- •6.3. Protease inhibitors
- •7. Impaired hepatic or renal function as defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 x upper limit of normal (ULN), bilirubin greater than 2 x ULN, serum creatinine greater than 2 x ULN
- •8. Persisting (greater than 8 weeks) severe pancytopenia due to previous therapy rather than disease (neutrophils less than 0.5 x 10^9/L or platelets less than 50 x 10^9/L)
- •9. Central nervous system (CNS) involvement with CLL
- •10. Cardiac dysfunction as defined as: myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) class III/IV heart failure, unstable angina, unstable cardiac arrhythmias
- •11. Any other malignancy which has been active or treated within the past 3 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions or endometrial carcinoma stage 1A grade 1
- •12. Unable to swallow orally administered medications
- •13. Patients with uncontrolled seizures
- •14. Active infection requiring systemic antibiotics, antifungal or antiviral drugs
- •15. Concurrent severe and/or uncontrolled medical condition (e.g. severe chronic obstructive pulmonary disease [COPD], severe Parkinsons's disease) or psychiatric condition
- •16. Women of child-bearing potential and men who have partners of child-bearing potential who are not willing to practise effective contraception for the duration of the study and for three months after the last study drug administration
- •17. Pregnancy or lactating women. Pre-menopausal women of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration.
研究者
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