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.

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

At registration
* Advanced stage mycosis fungoides (stage IIB-IV), or Sézary Syndrome.
* Prior debulking therapy with either gemcitabine or liposomal doxorubicin, 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 Sezary syndrome, Sezary cell burden has to be decreased by at least 50 percent after debulking.;All patients must receive one of the two permitted 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.
* Local low-dose/energy ionizing radiation therapy may be used as part of the debulking process to treat lesions that do not respond after three cycles of debulking chemotherapy.
* No other drug may be part of the debulking regimen. The use of low-dose steroids as premedication is allowed at the investigator*s discretion.
* Disease not appropriate for skin-directed therapy, per local institution standards.
* Disease not previously treated with intravenous chemotherapy (except for the permitted debulking agents, used for that purpose immediately prior to this protocol, as described above).
* In addition to antineoplastic cytotoxic agents, for purposes of this protocol, the definition of intravenous chemotherapy also includes:
* Denileukin diftitox
*Antibodies or antibody conjugates
* Age > 18 years.
* WHO performance status 0-2.
* Life expectance greater than 12 months
* Adequate organ function
* Cardiovascular status <= New York Heart Association (NYHA) category II (refer to Appendix D).
* Hepatic: Total Bilirubin <= 1.5 x UNL, alkaline phosphatase (ALP) <= 3 x UNL, alanine
aminotransferase (ALT, SGPT) <= 3 x UNL, aspartate aminotransferase (AST, SGOT) <= 3 x UNL
* Renal: Electrolytes including sodium, potassium, chloride, blood urea nitrogen (all creatinine < UNL, creatinine clearance >= 60 ml/min (measured or calculated according to the
method of Cockcroft and Gault, Appendix E), uric acid, phosphorus, calcium (all * Hematological: Hemoglobin >= 10 g/dl, absolute neutrophil count >= 1.5 x 109/L,
platelets >= 60 x 109 /L.
* Thyroid testing: free T4 and TSH anti-coagulation therapy (e.g. Vitamin K) to keep the International normalized ratio (INR) in the range of 2-3;* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.;* Female subjects of childbearing potential (defined as any female subject unless she meets at least one of the following criteria: Age >=50 years and naturally amenorrheic for >= 1 year {amenorrhea following cancer therapy does not rule out childbearing potential}, premature ovarian failure confirmed by a specialist gynacologist, previous bilateral salpingo-oophorectomy or hysterectomy, XY genotype, Turner syndrome or uterin

Exclusion Criteria

* Central nervous system involvement.
* Uncontrolled infectious disease, autoimmune disease, immunodeficiency, or history of either
splenectomy or splenic irradiation.
* 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.
* Pregnant or breast feeding subjects.
* Lapp lactase deficiency or history of glucose-galactose malabsorption.
*Radiation or drug-based therapy (including steroids) between registration and randomization.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease assessment will be performed every 8 weeks according to the EORTC-ISCL<br /><br>criteria.<br /><br>The primary (efficacy) endpoint is progression free survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Toxicity is assessed as a secondary endpoint. This study will use the<br /><br>International Common Terminology Criteria (CTCAE), version 4.0, for toxicity<br /><br>and adverse event reporting.</p><br>