EUCTR2006-006978-20-GB进行中（未招募）不适用
A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (vincristine sulfate liposomes injection) in Adult Patients with Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients with Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy
Hana Biosciences, Inc.0 个研究点目标入组 56 人开始时间: 2007年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age =18 years.
- •2 Have Philadelphia chromosome-negative ALL or lymphoblastic lymphoma
- •and be in second relapse or have failed two treatment lines of anti-leukemia
- •chemotherapy.
- •3 Have histologically or cytologically proven ALL and =10% bone marrow
- •blasts. If < 10% bone marrow blasts, subject must have histologically or
- •cytologically proven ALL and evaluable extramedullary disease.
- •4 Have achieved a complete response to at least one prior anti-leukemia therapy
- •as defined by a leukemia-free interval of = 90 days.
- •5 For subjects with a prior history of stem cell transplantation, have a 6 Have ECOG performance status 0–3.
- •7. Have normal renal and liver function as defined below within 14 days, inclusive, prior to first dose of Marqibo, unless the abnormality is considered attributable to leukemia:
- •a. Total bilirubin =2.0 x institutional upper limit of normal (ULN), unless the subject
- •has a known diagnosis of Gilbert’s disease. If a subject has Gilbert’s disease, he/she
- •can participate in this study, however must be monitored closely during the study.
- •b. Aspartate transaminase (AST, SGOT) or alanine transaminase (ALT, SGPT) =3 x
- •institutional ULN.
- •c. Serum creatinine =2.0 g/dL or calculated estimated creatinine clearance =50
- •mL/min/1.73 m2 based on Cockcroft and Gault formula, unless renal dysfunction is
- •considered due to hematologic malignancy.
- •8. Have never received prior Marqibo treatment.
- •9. For women of childbearing potential, have a negative serum or urine pregnancy test within 14 days prior to enrollment.
- •10. If female, the subject is post-menopausal, surgically sterilized, or willing to use
- •acceptable methods of birth control (e.g., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide or abstinence) from the Screening visit through 30 days after the last dose of Marqibo.
- •11. If male, the subject agrees to use an acceptable barrier method for ontraception from the Screening visit through 30 days after the last dose of Marqibo.
- •12. Before enrollment, the subject is capable of understanding and complying with
- •parameters as outlined in the protocol and able to sign a written informed consent
- •according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have Burkitt’s lymphoma or Burkitt’s leukemia
- •2. Have a history of Philadelphia chromosome-positive ALL and/or BCR/ABL
- •rearrangements documented by FISH or PCR.
- •3. Have active CNS disease. History of treated CNS disease is allowable. The CNS disease
- •must have resolved in order for the subject to be eligible.
- •4. Are eligible for stem cell transplantation. This implies that a suitable donor is readily available, the subject is willing to undergo stem cell transplantation, and the Investigator believes this is a better treatment option than Marqibo. This is at the Investigator’s discretion.
- •5. Are treated with any investigational agents or chemotherapy agents in the last 21 days before the first dose of Marqibo, unless full recovery from side effects has occurred or the subject has rapidly progressing disease judged to be life threatening by the Investigator.
- •6. Are receiving any other standard or investigational treatment for their leukemia.
- •a. Intrathecal chemotherapy for CNS prophylaxis is allowable.
- •b. The use of hydroxyurea (Hydrea®) to control leukocytosis is allowable but must be
- •tapered off by Day 14 of Course 1. From Day 15 of Course 1 on through the end of
- •study participation, hydroxyurea (Hydrea®) is not allowed.
- •c. Systemic corticosteroids must have been tapered off, preferably before the start of
- •study treatment, but no later than by Day 5 of Course 1. From Day 6 of Course 1 on
- •through the end of study participation, systemic corticosteroids are not allowed.
- •7. Have persistent chronic clinically significant toxicities from prior chemotherapy =Grade 2 (NCI CTCAE v3.0).
- •8. Have persistent =Grade 2 active neuropathy (NCI CTCAE v3.0).
- •9. Have a history of persistent =Grade 2 active neurologic disorders unrelated to
- •chemotherapy (including demyelinating form of Charcot-Marie-Tooth syndrome,
- •acquired demyelinating disorders, or other demyelinating condition).
- •10. Have a history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to vincristine or components of Marqibo (vincristine sulfate injection, sphingomyelin/cholesterol liposomes, sodium phosphate injection).
- •11. Are pregnant or breast-feeding women.
- •12. Have active serious infection not controlled by oral or intravenous antibiotics or
- •antifungals.
- •13. Have human immunodeficiency virus (HIV) positive status.
- •14. Have any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities.
- •15. Have any condition or circumstance which in the opinion of the Investigator would
- •significantly interfere with the subject’s protocol compliance and put the subject at
- •increased risk.
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