Lenalidomide Maintenance Post-debulking in Advanced CTCL

NCT01098656 | Terminated Phase 3 DMC

• 4 other identifiers: EORTC-21081EU-210202009-011020-65CELGENE-EORTC-21081
• Study Type: interventional
• Target: 21
• Locations: 8 countries
• Sites: 22

Brief 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.

Conditions

Lymphoma

Keywords

stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (5)

• 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

Study Arms (2)

lenalidomide

EXPERIMENTAL

Drug: lenalidomide

Observation

NO INTERVENTION

Interventions

lenalidomide DRUG

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)

lenalidomide

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (22)

Medical University of Graz

Graz, 8036, Austria

Location

Medical University Vienna - General Hospital

Vienna, 1090, Austria

Location

Cliniques Universitaires St. Luc

Brussels, Belgium

Location

Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

Brussels, Belgium

Location

U.Z. Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Helsinky University Central Hospital - Skin & Allergy Hospital

Helsinki, 00029, Finland

Location

Nouvel Hopital Estaing

Clermont-Ferrand, Cedex 1, 66003, France

Location

Chu de Bordeaux - Hopital Du Haut Leveque

Bordeaux, Pessac Cedex, 33604, France

Location

Chu Lyon - Centre Hospitalier Lyon Sud

Lyon, Pierre-Benite Cedex, 69495, France

Location

Chu Amiens - Hopital Sud

Amiens, 80054, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU de Reims - Hôpital Robert Debré

Reims, 51092, France

Location

Charite - Universitaetsmedizin Berlin - Campus Mitte

Berlin, Germany

Location

Johannes Gutenberg Universitaetskliniken

Mainz, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

Csu de Bellvitge (Institut Catala D'Oncologia)

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Universitario 12 De Octubre

Madrid, Spain

Location

UniversitaetsSpital Zurich - Division of Oncology

Zurich, Switzerland

Location

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

Guy'S and St Thomas' Nhs - St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

Christie Nhs Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Nottingham University Hospitals NHS Trust - City Hospital campus

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martine Bagot, MD

  Hopital Saint-Louis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 5, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

AU (2); BE (3); FI (1); CH (1); ES (2); GB (4); DE (3); FR (6)