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 Syndrome; MedDRA version: 13.1Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-25
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

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

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.
- All patients should receive one of the two recommended debulking
regimens:
* Gemcitabine administered on days 1, 8, and 15 of a 28-day cycle at a
dose of 1000 to 1200 mg/m2 intravenously over 30 minutes for a total
of four cycles.
(or)
* Liposomal Doxorubicin administered on days 1 and 15 of a 28-day
cycle at a dose of 20 mg/m2 intravenously over one hour for a total of
four cycles.
These recommended regimens can be altered according to local
institutional policies. In case of drug intolerance, the study regimen can
be switched from one regimen to the other.
- 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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- 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