NCT00100152终止1 期
A Phase I Study of a Gamma Secretase Inhibitor for Adult and Pediatric Patients With Relapsed or Refractory Acute T-Cell Lymphoblastic Leukemia and Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 50
研究概览
简要总结
A Notch signalling pathway inhibitor study in pediatric and adult patients with relapsed (worsening) or refractory (not responding to treatment) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically documented precursor T-cell acute lymphoblastic leukemia/lymphoma (T-ALL), relapsed or refractory to standard therapy, or not be a candidate for standard myelosuppressive chemotherapy due to age or comorbid disease.
- •Patient must have performance status <2 on the ECOG performance status for patients >16 years old; Lansky performance level >50 for patients 12 months to less than or equal to 16 years old.
- •Patient must have adequate renal and liver function as indicated by the laboratory values performed within 14 days of receiving the first dose of study drug.
- •Patient must have fully recovered from any chemotherapy and be greater than 2 weeks from radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea, intrathecal therapy, or immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant.
- •Patient must be greater than 2 months following bone marrow or peripheral blood stem cell transplantation and off all immunosuppressant therapy (with the exception of patients taking immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant).
- •Men and women of reproductive potential must use an effective contraceptive method while enrolled in the study.
- •Patient or the patient's legal representative must be able to understand the study and give written informed consent.
排除标准
- •Patient has had treatment with any investigational therapy during the preceding 30 days.
- •Patient has uncontrolled congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months.
- •Patient has known hypersensitivity to the components of study drug, its analogs, or to allopurinol.
- •Patient has active or uncontrolled infection.
- •Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Patient is pregnant or lactating.
- •Patient has any other severe concurrent disease which would make the patient inappropriate for entry into this study.
- •Patient is known to be HIV positive or who has an AIDS-related illness.
- •Patients with a "currently active" second malignancy, other than non-melanoma skin cancer should not be enrolled.
- •Patient has isolated CNS disease.
研究者
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