EUCTR2009-011020-65-NL
Active, not recruiting
Not Applicable
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.
European Organisation for Research and Treatment of Cancer0 sites105 target enrollmentMarch 17, 2010
ConditionsCutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary SyndromeMedDRA version: 12.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndrome
DrugsRevlimid
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cutaneous T-cell lymphoma: Mycosis Fungoides, Stage IIB to IV or Sézary Syndrome
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Enrollment
- 105
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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