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Lenalidomide in Treating Patients With Relapsed Mycosis Fungoides/Sezary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466921
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : November 16, 2020
Last Update Posted : December 1, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Lenalidomide may stop the growth of mycosis fungoides/Sezary syndrome by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with relapsed mycosis fungoides/Sezary syndrome.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: lenalidomide Phase 2

Detailed Description:



  • Determine the response rate and duration of response in patients with relapsed mycosis fungoides/Sézary syndrome treated with lenalidomide.
  • Determine the progression-free survival of patients treated with this drug.


  • Determine the toxicity of this drug in these patients.
  • Correlate the antiangiogenetic and costimulatory effects of this drug with clinical activity in skin biopsies from these patients.
  • Assess the specific immune effector cell recruitment and augmentation of antitumor response in these patients. (Northwestern University only)

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 2 courses. Patients with progressive disease are removed from study. Patients achieving complete response receive 2 additional courses of treatment beyond complete response. Patients achieving partial response or stable disease may continue to receive lenalidomide as above for up to 2 years. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients undergo tissue biopsies at baseline and on day 1 of course 2. Tissue specimens are analyzed for vessel density, presence of adhesion molecules, and immunophenotyping of dermal infiltrate.*

NOTE: *At Northwestern University only, blood and tissue samples from 5-10 patients are collected. Peripheral blood samples are analyzed for immune cell repertoire (CD4+, CD8+ T cells, NK cells, NKT cells, CD4+, CD25+ T-regulatory cells, monocytes, and dendritic cell subsets), cell surface molecules, and for TH1/TH2-associated cytokines, such as interleukin (IL)-2, IL-4, IL-10, IL-12, interferon gamma, and tumor necrosis factor alpha, by flow cytometry at baseline, day 15 of course 1, and at the end of course 1. Immunological activation is assessed by analyzing surface expression of CD45RO and CTLA-4 on CD4+ and CD8+ T cells in blood and skin samples. Skin specimens are stored for future research studies on predictive markers of lenalidomide activity.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma
Actual Study Start Date : April 19, 2005
Actual Primary Completion Date : April 5, 2010
Actual Study Completion Date : May 17, 2013

Arm Intervention/treatment
Experimental: Lenalidomide Drug: lenalidomide
10 mg daily orally administered on days 1 - 21 followed by 7 days rest of a 28-day cycle, increasing dose by 5 mg every cycle, up to a maximum of 25 mg.

Primary Outcome Measures :
  1. Response to Treatment [ Time Frame: After cycle 4 of treatment (1 cycle =28 days) ]

    In general response to treatment is defined as either complete response (CR) or partial response (PR) assessed using Composite Assessment (CA) of index lesion disease severity and is defined as the following:

    CR =CA ratio=0/no evidence of new disease (abnormal or pathologically positive lymph nodes, cutaneous or other tumor manifestations, visceral disease) present over 4 weeks. Patients with Sézary Syndrome must have no evidence of circulating Sézary cells (< 5% Sézary cells=not significant). Skin biopsy is required for documentation of CR. Confirmatory CT scans are required, if baseline CTs were abnormal.

    PR= CA ratio ≥0.5/no new clinically abnormal lymph nodes/no progression of existing clinically abnormal lymph nodes (<25%)/no new cutaneous tumors/no new pathologically positive lymph nodes or visceral disease in an area previously documented as-ve for at least 4 weeks. In patients with circulating Sézary cells at least a 50% reduction of malignant lymphocytes is required.

  2. Progression-free Survival (PFS) [ Time Frame: From time of treatment initiation until progression or death from any cause (up to a possible maximum of approximately 6 years) ]

    PFS is defined from the time of treatment initiation until documentation of progressive disease or death from any cause.

    Progressive disease is defined as (PD) ≥25% increase in CA ratio, ≥25% increase in no. or area of clinically abnormal lymph nodes/new tumors/new pathologically positive lymph nodes/visceral disease/an increase >25% in no. of Sézary cells.

  3. Duration of Response (DOR) [ Time Frame: From time of initial response until progressive disease (up to approximately 1 year) ]
    DOR is defined as time of initial documentation of response to the time of documentation of progression in patients who achieve either a complete response (CR) and partial response (PR)

Secondary Outcome Measures :
  1. Number of Patients Who Experience Toxicity as Assessed by NCI CTCAE v3.0 [ Time Frame: From treatment initiation until up to 30 days post treatment with possible 4 cycles of initial treatment (1 cycle =28 days) and up to 2 further years of treatment permitted if meeting response criteria ]

    Toxicity is defined as the number of patients who patients who experienced an adverse event that was determined to be at least possibly related to study drug and determined to be a grade 3 or higher in severity as assessed by the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where generally:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE

Other Outcome Measures:
  1. Specific Immune Effector Cell Recruitment and Augmentation of Antitumor Response at Baseline and Day 15 of Course 1 (Northwestern University Only) [ Time Frame: After all patients have completed thru day 15 of course 1. ]
  2. Correlation of Antiangiogenetic and Costimulatory Effects With Clinical Activity at Baseline and After Course 1 [ Time Frame: After all patients have completed 1 course ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed mycosis fungoides/Sézary syndrome

    • Stage IA-IVB disease
  • Must have failed ≥ 1 prior topical treatment, including any of the following:

    • Steroids
    • Nitrogen mustard
    • Retinoids
    • Phototherapy
    • Photochemotherapy
    • Radiotherapy
    • Total skin electron beam
  • Measurable disease with ≥ 1 indicator lesion designated prior to study entry

    • Erythrodermic patients are eligible


  • ECOG performance status 0-2
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 2.2 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile women must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy
  • Fertile men must use effective contraception during and for ≥ 4 weeks after completion of study therapy
  • No other malignancy within the past 5 years except treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, or surgically removed melanoma in situ of the skin (stage 0), with histologically confirmed free margins of excision and no current evidence of disease
  • No acute infection requiring systemic treatment
  • No known allergic reaction or hypersensitivity to thalidomide


  • See Disease Characteristics
  • More than 4 weeks since prior topical therapy, systemic chemotherapy, or biological therapy
  • No prior stem cell transplantation
  • No other concurrent systemic antipsoriatic or anticancer therapies, including radiotherapy, thalidomide, or other investigational agents
  • No other concurrent topical agents except emollients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00466921

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United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Northwestern University Identifier: NCT00466921    
Other Study ID Numbers: NU 04H5
P30CA060553 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2007    Key Record Dates
Results First Posted: November 16, 2020
Last Update Posted: December 1, 2020
Last Verified: October 2020
Keywords provided by Northwestern University:
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
Additional relevant MeSH terms:
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Mycosis Fungoides
Sezary Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents