E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049085 |
E.1.2 | Term | Antifungal prophylaxis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the safety profile of a prophylactic antifungal LAMB treatment of 7 mg/kg, administered as a weekly intravenous infusions over two hours, during induction treatment of acute lymphoblastic leukemia of elderly patients undergoing chemotherapy with GMALL-Elderly 1/2003 protocol for four weeks. |
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E.2.2 | Secondary objectives of the trial |
• Incidence and time to onset of possible, probable or proven IFI according to EORTC-MSG criteria within the 12 weeks following the initiation of prophylaxis treatment.
• IFI free time as % of follow-up time
• The incidence of pulmonary infiltrates within 12 weeks following initiation of prophylaxis.
• The need for additional systemic antifungal therapy within 12 weeks following initiation of prophylaxis.
• The survival rate and incidence of mortality related to fungal infection at the end of prophylaxis treatment and within 12 weeks after prophylaxis treatment initiation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female patients
• Patients with ALL undergoing first induction chemotherapy within the GMALL-Elderly 1/2003 protocol
• Females of childbearing potential (less than 2 years post-menopausal) must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline
• Understanding of the study's rational and procedures documented in the patient's informed consent
• Ability and agreement to comply with all study requirements
• Patient willing to attend hospital appointments for each visit (infusions will be performed in hospital, under strict medical supervision)
• Written informed consent must be obtained before any study protocol-related procedure is carried out |
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E.4 | Principal exclusion criteria |
• Known hypersensitivity to amphotericin B or LAMB or any of its constituents, in particular known history of anaphylactic reaction to amphotericin B or LAMB or any of its constituents
• Signs or symptoms of IFI or previous proven or probable IFI in the medical history
• Evidence for pulmonary infiltrates in chest CT and/or x-ray of the chest, (only when a chest CT/x-ray is done at baseline)
• Estimated creatinine clearance (ECC) ≤ 60 mL/min (Cockcroft-Gault); in such cases the body surface adjusted Modification Diet in Renal Disease (MDRD) glomerular filtration rate (GFRMDRD) should be calculated. If the body surface adjusted GFRMDRD is above 60 mL/min, the patient can be included
• Patient with moderate or severe liver disease as defined by AST, ALT or alkaline phosphatase (AP) > 5 times the upper limit of normal (ULN), or bilirubin > 3 times ULN
• Patients who are unlikely to survive more than 1 month
• Febrile patients (≥ 38.5°C)
• Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
• Any severe co-morbidity other than the underlying hematological disease (ALL), which in the investigator's judgment may interfere with study evaluations or affect the patient's safety
• Patients previously included in this study
• Patients who have taken any investigational drug within the last 30 days prior to the inclusion except drugs used according to the GMALL-Elderly/2003 protocol
• Patients who participate in another clinical trial except anti-cancer trials |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to characterize the safety profile for the prophylaxis treatment course. This will be achieved by descriptive statistics on adverse events and clinical laboratory data. No statistical tests of significance are planned.
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |