Status:
COMPLETED
Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Celgene Corporation
Conditions:
Cutaneous Lupus Erythematosus (CLE)
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label ind...
Detailed Description
Cutaneous lupus erythematosus (CLE) is a chronic and often disabling disease which affects the skin. Many patients experience scarring and inflammation of the skin, which often occur on the face. Mode...
Eligibility Criteria
Inclusion
- Subjects must understand and voluntarily sign Informed Consent and HIPAA forms.
- Males and females over the age of 18 at the time of signing informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements
- Subjects must have biopsy proven Cutaneous Lupus Erythematosus (CLE) either in the form of Discoid Lupus Erythematosus (DLE) or Subacute Lupus Erythematosus (SCLE), with or without systemic involvement.
- Subjects must have grade II erythema in at least three skin locations as defined by the Cutaneous Lupus Activity and Severity Index (CLASI).
- Subjects must have failed standard treatment with hydroxychloroquine (Plaquenil) for up to three months.
- Female subjects who are not pregnant.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional method AT THE SAME TIME, at least 28 days before starting to take lenalidomide (Revlimid®). FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
- If pregnancy or a positive pregnancy test is noted in a study subject or in the partner of a male study subject during study participation, the study drug must be discontinued immediately.
Exclusion
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
- Female subjects who are pregnant, plan to be pregnant during the study, or who are breastfeeding.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk for study participation, or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Prior history of deep vein thrombosis (DVT).
- Prior history of pulmonary embolus (PE).
- Known positive for HIV viral DNA by qPCR.
- Positive hepatitis B surface antigen, or hepatitis C.
- Platelet count \< 50,000/mcL.
- Absolute neutrophil count \< 750/mcL
- Lymphopenia \< 500/mcL.
- Have current signs or symptoms of severe progressive or uncontrolled renal disease (creatinine ≥1.5 x ULN).
- If female, unwillingness to use one highly effective method and one additional method of birth control.
- If male, unwillingness to use a latex condom during intercourse with females of childbearing potential.
- Continued therapy with thalidomide.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00633945
Start Date
November 1 2007
End Date
October 1 2009
Last Update
February 9 2023
Active Locations (1)
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1
Hospital of the University of Pennsylvania, Department of Dermatology
Philadelphia, Pennsylvania, United States, 19104