Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnoses of advanced T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome

• Stage IIB-IV disease

• Achieved complete or partial response after undergoing prior debulking therapy with 1 of the following recommended* regimens with or without radiotherapy**:

• Gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 of a 28-day course at a dose of 1,000 to 1,200 mg/m² for a total of four courses

• Pegylated liposomal doxorubicin hydrochloride IV over 1 hour on days 1 and 15 of a 28-day course at a dose of 20 mg/m² for a total of four courses NOTE: *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.

NOTE: **Local low-dose/energy-ionizing radiation therapy allowed as part of the debulking process to treat lesions that do not respond after 3 courses of debulking chemotherapy.

• Sézary cell burden must be decreased by at least 50% after debulking in patients with Sézary syndrome

• Disease not appropriate for skin-directed therapy per local institution standards

• No disease progression between registration and randomization

• No CNS involvement

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• Life expectancy > 12 months

• Hemoglobin ≥ 10 g/dL

• Absolute neutrophil count ≥ 1.5 x 10^9/L

• Platelet count ≥ 60 x 10^9/L

• Total bilirubin ≤ 1.5 times upper limit of normal (UNL)

• Alkaline phosphatase ≤ 3 times UNL

• ALT/AST ≤ 3 times UNL

• Electrolytes (including sodium, potassium, and chloride) normal

• Creatinine normal

• Creatinine clearance ≥ 60 mL/min

• Uric acid and calcium normal

• Free T4 and TSH ≤ 1.5 times ULN

• Patients with a buffer range from the normal values of +/- 10% for hematology and biochemistry are acceptable

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception 4 weeks prior to, during, and for 4 weeks after completion of study therapy

• Males must agree not to donate semen during and for 1 week after completion of study therapy

• Patients with high risk for or history of a thromboembolic event must agree to receive prophylactic anticoagulation therapy (e.g., vitamin K) to keep INR in the range of 2-3

• No New York Heart Association class III-IV disease

• No blood donating during and for 1 week after completion of study therapy

• No uncontrolled infectious disease, autoimmune disease, or immunodeficiency

• No second malignancies within the past 3 years except surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal or squamous cell carcinoma of the skin

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• No Lapp lactase deficiency or history of glucose-galactose malabsorption

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No other prior intravenous chemotherapy for this cancer

• For purposes of this protocol, the definition of intravenous chemotherapy also includes denileukin diftitox, antibodies, or antibody conjugates

• No prior splenectomy or splenic irradiation

• No concurrent topical corticosteroids

• Concurrent systemic corticosteroids allowed for treatment of tumor flare reactions

• No radiation or drug-based therapy (including steroids) between registration and randomization

• No other concurrent drugs (including steroids) during the debulking regimen

• Low-dose steroids as premedication allowed at the investigator's discretion

• No other concurrent anticancer treatments

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

Martine Bagot, MD

Study Chair

Leslie Herman, PhD		Ph: +32 2 774 15 11
		Email: leslie.herman@eortc.be

Austria
	Graz
	Landeskrankenhaus/Universitatskliniken Graz
	Vienna
	Medical University Vienna - General Hospital
Belgium
	Brussels
	Cliniques Universitaires Saint-Luc
	Hopital Universitaire Erasme
	Leuven
	U.Z. Leuven - Campus Gasthuisberg
Finland
	Helsinki
	Helsinki University Central Hospital
France
	Amiens
	CHU Amiens - Hopital Sud
	Bordeaux
	Hopital Haut Leveque
	Clermont-Ferrand
	Hopital D'Estaing
	Lyon
	Centre Hospitalier Lyon Sud
	Paris
	Hopital Saint-Louis
		Contact Person	Ph: 33-1-5372-2093
			Email: martine.bagot@sls.aphp.fr
	Reims
	CHU de Reims - Hôpital Robert Debré
Germany
	Berlin
	Charite - Universitaetsmedizin Berlin - Campus Mitte
	Mainz
	Johannes Gutenberg Universitaetskliniken
	Minden
	Klinikum Minden
Spain
	L'Hospitalet De Llobregat
	Csu de Bellvitge (Institut Catala D'Oncologia)
	Madrid
	Hospital Universitario 12 de Octubre
Switzerland
	Zurich
	UniversitaetsSpital Zurich - Division of Oncology
United Kingdom
	Glasgow
	Beatson West of Scotland Cancer Centre
	London
	Guy's Hospital
	Manchester
	Christie Hospital
	Nottingham
	Nottingham City Hospital

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01098656
Information obtained from ClinicalTrials.gov on October 09, 2012

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