E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with refractory or relapsed advanced stages of mycosis fungoides (stage IIb, IVa, or Ivb) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10028484 |
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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 |
The primary objective of this trial is to determine the antitumor activity of the study treatment for patients with refractory or relapsed advanced stages of mycosis fungoides |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess the impact of the trial treatment on the duration of objective response, the time to progression and also to characterize the safety profile of liposomal encapsulated doxorubicin (Caelyx™) in patients with refractory or relapsed advanced stage of mycosis fungoides |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Histopathologically confirmed diagnosis of Mycosis fungoides * stage IIb, IVa, or Ivb - No CNS involvement and no Erythroderma (T4), - Refractory or recurrent disease after at least two or more previous therapies(steroids local and/or systemic, retinoids, PUVA, IFN-a, local BCNU, systemic chemotherapy, etc), - Patients requiring systemic treatment with steroids, for any reason, at the moment of study entry are excluded. - Prior systemic chemotherapy is allowed if all the following conditions are met: 1. Antracycline cumulative dose <200mg/m2, 2. No allergy to anthracyclines 3. Low dose MTX (weekly dose<30 mg) - No administration of chemo-, immuno- or radiotherapy within the previous 2 weeks before trial entry. Patients must have completely recovered from all acute toxicities (excluding alopecia). - Age >18 years, - Karnofsky performance index ≥ 60 - No other prior or concurrent primary malignant tumor (except adequately treated in situ carcinoma of the cervix uteri or squamos or basal cell skin carcinoma). - No active infection requiring specific therapy (antibiotics, anti HIV therapy), - Left ventricular ejection fraction within normal limits (WNL) for each institution measured by echocardiography or by radionuclide angiocardiography, - Adequate hematologic function (hemoglobin > 10g/dl, WBC >2x109/l, platelets > 75000/mm3, neutrophiles >1.5x109/l), - Adequate renal and liver functions (serum creatinine and serum bilirubin ≤ 1.5 x the upper limit of normal for the institution and SGOT, SGPT ≤ 2.5 x the upper limit of normal for the institution), - Female patients potentially childbearing and without effective contraception, pregnant or lactating are excluded. Women of childbearing potential must have a negative pregnancy test within one week before entry into the trial. - Male patients who agree to practice an effective method of contraception during the entire period of treatment, - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial, - Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. |
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E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the response rate defined as the proportion of patients who achieve a complete clinical response (CCR) or partial response (PR) |
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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 | 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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |