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Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

Phase II Trial of CC-5013 (Lenalidomide, Revlimid®) in Patients With Cutaneous T-Cell Lymphoma



- 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

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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate and duration of response

Outcome Time Frame:

After all patients have progressed

Safety Issue:


Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:

NU 04H5



Start Date:

February 2005

Completion Date:

February 2014

Related Keywords:

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



M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Stanford Cancer Center Stanford, California  94305-5824