A PHASE II CLINICAL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF DEPOCYTE® (CYTARABINE LIPOSOME INJECTION) FOR THE TREATMENT OF CNS RELAPSE IN ADULT PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA OR HIGH-GRADE LYMPHOMA - DepoCyte® in ALL / NHL CNS relapse

Dieter Hoelzer, MD,PhD0 个研究点目标入组 20 人开始时间: 2005年10月24日最近更新: 2013年4月29日

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: 20

研究概览入排标准研究者记录与标识符相似试验

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

•- Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-
•Lymphoma (Burkitt/Burkitt-like) and CNS relapse.
•CNS involvement must be demonstrated by:
•* A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR
•* Characteristic signs and symptoms of neoplastic meningitis PLUSan MRI or CT scan indicating the presence of meningeal involvement.
•Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX; HDAC, Thiotepa) can be postponed for at least 2 weeks.
•- Karnofsky >= 60%
•- Age >= 18 years
•- Free of uncontrolled infection
•- Recovery from grade III/IV toxicities attributable to prior treatment with the
•exception of hematotoxicity
•- The patient must not be pregnant or breast feeding. If the patient is a female of
•child-bearing potential she must have a negative (urine or serum) pregnancy test
•and be using effective methods to prevent pregnancy.
•- No severe heart, lung, liver or kidney dysfunction
•- The patient or guardian must be competent to provide informed consent and must
•provide written informed consent prior to the initiation of study procedures.
•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

•- Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX
•or cytarabine or triple (MTX, ARA-C, dexamethasone) therapy
•- History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal
•therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine
•induced peripheral neuropathy is accepted)
•- Prior CNS relapse < 1 month before

研究者

发起方

Dieter Hoelzer, MD,PhD

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