RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome. PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.
OBJECTIVES: * To determine if observation versus lenalidomide maintenance therapy after debulking with gemcitabine hydrochloride or pegylated liposomal doxorubicin hydrochloride with or without radiotherapy prolongs progression-free survival of patients with advanced stage IIIB or IV T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome not previously treated with other intravenous chemotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to institution, response to debulking treatment (complete response vs partial response), and disease (mycosis fungoides \[MF\] vs erythrodermic MF/Sézary syndrome). Patients are randomized to 1 of 2 treatment arms. * Arm I: Beginning 4-6 weeks after completion of prior debulking therapy, patients undergo observation for 560 days. * Arm II: Beginning 4-6 weeks after completion of prior debulking therapy, patients receive oral lenalidomide once a day on days 1-21. Treatment repeats every 28 days for 20 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks and then every 12 weeks thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
The starting dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles. Dosing is continued or modified based upon clinical and laboratory findings (dose reductions: 20 mg, 15 mg, 10 mg and 5 mg)
Medical University of Graz
Graz, Austria
Medical University Vienna - General Hospital
Vienna, Austria
Cliniques Universitaires St. Luc
Brussels, Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
Brussels, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
Helsinky University Central Hospital - Skin & Allergy Hospital
Helsinki, Finland
Nouvel Hopital Estaing
Clermont-Ferrand, Cedex 1, France
Chu de Bordeaux - Hopital Du Haut Leveque
Bordeaux, Pessac Cedex, France
Chu Lyon - Centre Hospitalier Lyon Sud
Lyon, Pierre-Benite Cedex, France
Chu Amiens - Hopital Sud
Amiens, France
...and 12 more locations
Progression-free survival
Overall survival
Progression-free survival as assessed by hematogenous disease criteria
Acute and late toxicity
Conversion rate
Rate of occurrence of second cancers at any site
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