E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mycosis Fungoides type CTCL |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028502 |
E.1.2 | Term | Mycosis fungoides refractory |
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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 is to determine the efficacy of HuMax-CD4 in patients with MF who are refractory or intolerant to treatment with Targretin and one other standard therapy. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to explore safety and relief of symptoms and characterize the pharmacokinetic profile of HuMax-CD4 in patients with MF who are refractory or intolerant to treatment with Targretin and one other standard therapy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. A biopsy compatible with the diagnosis of MF with a CD4 positive phenotype within 6 months of study entry
2. MF stage IB to IVB (highest stage ever)
3. Refractory to or intolerant to at least two prior therapies, one being Targretin (or combinations hereof), and the other being the current standard therapy at each institution. Stage 1 patients are only required to be refractory or intolerant to at least one prior current standard therapy
4. WHO performance status 0, 1 or 2
5. Age >= 18 years
6. Following receipt of verbal and written information about the study, the patient must provide signed consent before any study related activity is carried out |
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E.4 | Principal exclusion criteria |
1. Sezary syndrome
2. Primary cutaneous anaplastic large cell lymphoma
3. Lymphomatoid papulosis
4. Histopathological evidence of sheets of large cells (from skin or nodes) or poorly differentiated tumors
5. Prior treatment with combination chemotherapy within six months
6. Prior treatment with Total Skin Electron Beam (TSEB) therapy within one year
7. Prior treatment with Campath (alemtuzumab)
8. Prior treatment with more than three regimens of single agent chemotherapy
9. Prior treatment with pentostatin within two years 17. Known or suspected positive serology for HIV
18. Known or suspected positive serology for hepatitis B or C
19. Signs or symptoms of CNS involvement
20. Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
21. Prior treatment with anti-CD4 monoclonal antibodies
22. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
23. Breast feeding women or women with a positive pregnancy test at Visit 1
24. Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate defined as proportion of patients achieving CR, CCR and PR as assessed by Physicianメs Global Assessment of Clinical Condition (PGA) during treatment and 8 weeks of follow-up |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | 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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |