ISRCTN15257573已完成1 期
Phase I/II study combining humanised anti-CD20 (veltuzumab), anti-CD22 (epratuzumab) or both monoclonal antibodies with intensive chemotherapy in adults with recurrent B-precursor acute lymphoblastic leukaemia (ALL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged between 16 and 65 years, either sex
- •2. Confirmed diagnosis of first recurrence of B-precursor ALL (according to the World Health Organization [WHO] classification)
- •3. First complete remission (CR1) greater than 6 months
- •4. WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 and well enough to receive intensive combination chemotherapy
- •5. Negative pregnancy test in women of childbearing potential. Women will not be considered of child bearing potential if they have undergone surgical removal of the uterus or are post menopausal and have been amenorrhoic for at least 24 months.
- •6. Patients must have a cardiac ejection fraction of greater than 50%
- •7. Patients must have adequate organ function:
- •7.1. Renal function ? serum creatinine less than 2.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) greater than 50 ml/min (measured EDTA or estimated creatinine clearance, e.g., Cockcroft & Gault)
- •7.2. Liver function - bilirubin/alanine aminotransferase (ALT) less than 2.5 x ULN
- •8. Patients must be able to comply with the study schedule
排除标准
- •1. Patients with Philadelphia positive (Ph +ve) ALL
- •2. Patients at 2nd or greater relapse of their ALL
- •3. Patients should not have received chemotherapy for relapsed ALL (except corticosteroids for a maximum of 5 days, before joining the study)
- •4. Patients who have already received greater than 340 mg/m^2 daunorubicin (or equivalent total anthracycline dose) therapy
- •5. Patients who have received prior mediastinal radiotherapy
- •6. Patients with co-morbidities: e.g. uncontrolled hypertension and or poorly controlled diabetes which in the PI's opinion makes them unsuitable for the study
- •7. Patients with severe psychiatric disorders which in the PI's opinion makes them unsuitable for trial participation
- •8. Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are post-menopausal (that is amenorrheic for 24 months).
- •9. Females of childbearing potential must have a negative pregnancy test within 7 days prior to starting the study
- •10. Females must not be breastfeeding
- •11. Patients may not receive any other investigational agent during the study
- •12. Patients should not have received any antibody therapy within 9 months of joining this study
研究者
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