Open-label, Dose escalation, followed by Double-blind, Randomized, Two-dose, Parallel Group, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin(bexarotene) and one other Standard Therapy - ND
- Conditions
- Mycosis Fungoides type CTCLMedDRA version: 9.1Level: LLTClassification code 10028502Term: Mycosis fungoides refractory
- Registration Number
- EUCTR2006-003353-24-IT
- Lead Sponsor
- GENMAB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
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
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Objective response rate defined as proportion of patients achieving CR, CCR and PR as assessed by Physician?s Global Assessment of Clinical Condition (PGA) during treatment and 8 weeks of follow-up
- Secondary Outcome Measures
Name Time Method