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
- Conditions
- Acute lymphoblastic leukaemia
- Registration Number
- EUCTR2005-000173-21-AT
- Lead Sponsor
- Dieter Hoelzer, MD,PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method