Acute lymphoblastic leukaemia
Conditions
Interventions
Trade Name: DepoCyte
Product Name: DepoCyte
Product Code: ---
Pharmaceutical Form: Suspension for injection
Sponsors
Dieter Hoelzer, MD,PhD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate after one application of DepoCyte® (The objective is to confirm efficacy and safety of DepoCyte® for treatment of CNS relapse in adult patients with acute lymphoblastic leukemia or very aggressive lymphoma);Secondary Objective: - Reponse rate at later time-points - Toxicity according to WHO - Death in induction and in CR - Time to neurological progression - The frequency of improvement in pre-existing meningeal-disease related neurological symptoms - Karnofsky Performance Status - Survival (all-cause and meningeal disease-specific);Primary end point(s): The primary efficacy endpoint will be · response rate after one application of DepoCyte® Further endpoints are: · Reponse rate at later time-points · Toxicity according to WHO · Death in induction and in CR · Time to neurological progression · The frequency of improvement in pre-existing meningeal-disease related neurological symptoms · Karnofsky Performance Status · Survival (all-cause and meningeal disease-specific | — |
Countries
Austria
Outcome results
None listed