ACTRN12611000814976已完成2 期
A phase II trial of an intensive pediatric protocol incorporating post-induction stratification based on minimal residual disease levels for the treatment of adolescents aged 15 years and above, and young adults aged up to 40 years, with newly diagnosed A
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 86 人开始时间: 2011年8月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
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
- 15 Years 至 40 Years（—）
- 性别
- All
入选标准
- •All of the following criteria must be satisfied for registration on the study.
- •1. A morphological diagnosis of ALL byWHO criteria, confirmed by immunophenotyping and cytogenetics. All clinico-pathological subtypes will be eligible, except for mature B or Burkitt ALL (L3).
- •2. Has provided written, informed consent
- •3. Available for follow up for at least 3 years
- •4. Males capable of parenting a child and women of childbearing potential must be using a medically acceptable and adequate method of contraception while undergoing protocol treatment and for 28 days following the last dose of protocol treatment. Note: due to a potentially increased risk of thrombosis in asparaginase containing regimens, cessation of the combined oral contraceptive in female patients should be considered and an alternative medically appropriate form of contraception be instituted.
- •5. Bone marrow blast count >/= 20%
- •6. Adequate renal and hepatic function at Screening as defined by:
- •a. Total bilirubin <2.5 x ULN unless medically correctable
- •b. Serum creatinine less than or equal to 200 micromol/L unless medically correctable
- •7. Normal left ventricular ejection fraction, according to institutional criteria. If the clinical circumstances require that treatment must be given urgently before this can be ascertained, the absence of clinical cardiac impairment is acceptable, provided that a normal left ventricular ejection fraction is confirmed prior to the first consolidation cycle.
- •8. An ECOG performance status score of 0-3 at Screening
排除标准
- •Presence of any of the following criteria will exclude the subject from registration on the study.
- •1. Subjects aged less than 15 or more than 40 years at Screening
- •2. Patients known to have Philadelphia chromosome-positive disease
- •3. Presence of serious cardiac, pulmonary, hepatic or renal disease.
- •4. Previous treatment for ALL or history of cancer (other than basal cell skin cancer or carcinoma of the cervix in situ, or other localised cancer treated by surgical excision only more than 5 years earlier without evidence of recurrence in the intervening period).
- •5. Contraindication to the use of the study drugs.
- •6. Positive for HIV, or evidence of uncontrolled Hepatitis B or C infection
- •7. Severe active infection
- •8. Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study
- •9. 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.
- •Pregnancy-Women who are pregnant at the time of diagnosis will not be excluded from the trial per se. The specific circumstances will require discussion between the patient, the hematologist responsible for her care, and the attending obstetrician. The management plan should then be discussed with one of the study
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