A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma.

• Conditions: Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome; MedDRA version: 14.1Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-011020-65-FI
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-21
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

? Advanced stage mycosis fungoides (stage IIB-IV), or Sézary Syndrome.
? Prior debulking therapy with either mono-chemotherapy, Poly-chemotherapy/combination chemo and radiotherapy or radiotherapy alone (e.g. Total Skin Electron Beam body radiation [TSEB]) (according to local institutional guidelines) resulting in complete or partial response as defined in this protocol's Evaluation criteria chapter. At the time of registration, patients provide consent for the collection of this pre/post debulking assessment information.
? For patients with Sézary syndrome, Sézary cell burden has to be decreased by at least 50 percent after debulking.
? Local low-dose/energy ionizing radiation therapy may be used as part of the debulking process in combination with chemotherapy.
? High dose steroids may be used as part of the debulking regimen as per local institution protocols, but must have been discontinued by the end of debulking and at the time of disease response assessment.
? Disease not appropriate for skin-directed therapy, per local institution standards.
? Disease not previously treated with intravenous anti-neoplastic agents (except for the debulking agents, used for that purpose immediately prior to this protocol).
? Age > 18 years.
? WHO performance status 0-2.
? Life expectance greater than 12 months.
? Patients with high risk for or history of a thromboembolic event must agree to receive prophylactic anti-coagulation therapy to keep the International normalized ratio (INR) in the range of 2-3.
? No second malignancies in the 3 years prior to study entry with the exception of surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal/squamous cell carcinoma of the skin.
? Female subjects of childbearing potential (as defined in the protocol) must agree to use an appropriate form of contraception, as defined in chapter 3 'Patient seclection criteria'.
? Male subjects must agree to use condoms throughout study drug therapy and follow guidelines, as described in chapter 3 'Patient seclection criteria'.
? Written informed consent must be given according to the International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline on Good Clinical Practice (ICH/GCP), and national/local regulations.
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

? Central nervous system involvement.
? Uncontrolled infectious disease, autoimmune disease, immunodeficiency, or history of either splenectomy or splenic irradiation.
? No pregnant or breast feeding subjects.
? No Lapp lactase deficiency or history of glucose-galactose malabsorption.
? Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified