Clinical Trial TitleA clinical study to demonstrate safety and efficacy of E7777 (denileukin diftitox) in persistent or recurrent cutaneous T-cell lymphoma.
Clinical Trial Protocol Description:
To provide E7777 (study drug) in treatment for patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) and to collect additional data on treatment safety.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a histopathologic diagnosis of CTCL (mycosis fungoides or Sezary syndrome), confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.
- Have a CD25 assay-positive tumor, defined as detectable CD25 on ≥ 20% of total lymphoid infiltrate in biopsied skin lesions by immunohistochemistry, assessed by central pathology laboratory. Results obtained at screening or from an archival skin biopsy (≤ 6 months) can be used as long as the test was performed by the study-designated central laboratory. Re-biopsy is required if the subject had disease progression or relapse since the last biopsy, or had received anticancer therapy since the last biopsy.
- Have a history of prior therapies for CTCL as follows: must have had prior therapy; any number of prior therapies allowed. Topical treatments (except topical chemotherapy) and steroids are not considered as prior therapies. Prior therapies include: cytotoxic chemotherapy, combination cytotoxic chemotherapy, electron beam radiotherapy (EBRT), phototherapy (e.g., PUVA or UVB), photophoresis, interferon, topical chemotherapy (e.g., carmustine, nitrogen mustard), systemic retinoids, cyclosporin A (≥4 mg/kg/d for ≥1 month), or histone deacetylase inhibitors. Repeated use of the same agent counts as one therapy, unless part of a different combination regimen.
- Have a minimum wash-out period of 4 weeks after previous CTCL therapy is recommended before the first dose of E7777. Subjects must have recovered from any adverse effects from any previous CTCL therapy before starting study drug. A shorter washout may be allowed if subject is experiencing progressive disease despite ongoing treatment.
You will be excluded from the study if any of the following criteria apply to you:
- Have CTCL disease with CNS involvement.
- Have had prior denileukin diftitox therapy.
- Have used topical steroids within 14 days of day 1 of initial therapy, with the following exception: Topical steroids or systemic low dose steroids (≤ 10 mg/day prednisone) are allowed in subjects with erythroderma who have been on corticosteroids for a prolonged period of time and where discontinuation may lead to rebound flare in disease. The concomitant steroid medication is allowed as long as the type of steroid, route of administration, and steroid dose remain the same as the subject had been receiving for a prolonged period of time.
- Have had prior malignancy other than CTCL within past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).
This is a partial list of inclusion and exclusion criteria.