A phase III study of lenalidomide maintenance after debulking with gemcitabine or liposomal doxorubicin +/- radiotherapy in patients with advanced cutaneous T-cell lymphoma not previously treated with intravenous chemotherapy.
- Conditions
- Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 12.0 Level: LLT Classification code 10028508 Term: Mycosis fungoides/Sezary syndrome
- Registration Number
- EUCTR2009-011020-65-FR
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
- Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome.
- Partial or complete response to a specific debulking regimen consisting of either gemcitabine or liposomal doxorubicin no more than 6 weeks prior to randomization. It is acceptable for patients entering the study to have received local radiotherapy for symptom control during the debulking period.
- Fit for chemotherapy (adequate organ function, as reflected by creatinine clearance, liver function tests and hematopoietic indices).
- Patient informed consent.
- WHO Performance status 0-2.
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
- Disease previously treated by intravenous chemotherapy (gemcitabine or caelyx
are allowed) used in the debulking regimen.
- Disease not appropriate for skin-directed therapy (per local institution standards)
- Contraindications to lenalidomide treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method