E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute lymphoblastic leukaemia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
- 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) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |