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Phase III

A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma

  • Study HIC#:2000020362
  • Last Updated:07/12/2021

The purpose of this trial is to assess the efficacy and safety of E7777 (improved purity ONTAK) in patients with persistent and recurrent cutaneous T-cell lymphoma. A lead-in dose-finding part will be used to determine the dose of E7777 that should be used to test efficacy and safety.

  • Age18 years and older
  • GenderBoth
  • Start Date07/19/2017
  • End Date06/30/2019

Trial Purpose and Description

This is a multicenter, open-label, single-arm study of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL). The study will consist of an initial lead-in phase (in which a dose of E7777 will be selected), followed by the Main Study. Participants will move through three phases while on study: Pretreatment Phase, Treatment Phase, and Extension Phase and a Follow-up Period.

Eligibility Criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be included in the study:

  1. Age greater than or equal to 18 years.
  2. Histopathologic diagnosis of CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]), confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.
  3. CD25 assay-positive tumor, defined as detectable CD25 on greater than or equal to 20% of total lymphoid infiltrate in biopsied skin lesions by immunohistochemistry.
  4. CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).
    • Lead-In Phase: Stage IA - IV, except participants with CNS involvement.
    • Main Study: Stage IA - IVA1 (excludes IVA2 and IVB), as follows:
    • However, only N0 and N1 are allowed;
    • Excludes known CTCL involvement of the bone marrow
  5. 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.
  6. A minimum washout period of 4 weeks after previous CTCL therapy is recommended before the first dose of E7777.
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 in the Lead-In Phase and performance status of 0 or 1 in the Main Study.
  8. Life expectancy greater than or equal to 3 months in the Lead-In Phase and greater than or equal to 12 months in the Main Study.
  9. Adequate bone marrow reserves as evidenced by:
    • platelets greater than or equal to 100,000/mm3 (100 x 10^9/L)
    • clinically stable hemoglobin greater than or equal to 9 g/dL (90 g/L) and hematocrit greater than or equal to 27% without transfusion support
  10. Normal hepatic function as evidenced by:
    • bilirubin and alkaline phosphatase less than or equal to 1 x the upper limit of normal (ULN).
    • aspartate aminotransferase (AST) less than or equal to 75 U/L and alanine aminotransferase (ALT) less than or equal to 100 U/L.
    • albumin greater than or equal to 3.0 g/dL (30 g/L).
  11. Adequate renal function as evidenced by serum creatinine less than or equal to 1.8 mg/dL (158 umol/L) OR calculated creatinine clearance greater than or equal to 50 mL/min (per the Cockcroft-Gault formula) with less than 2+ protein OR 24- hour urine creatinine clearance greater than or equal to 50 mL/minute with 24- hour urine protein less than 1g.
  12. Provide written informed consent prior to any study-specific screening procedures.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from the study:

  1. CTCL disease with CNS involvement
  2. Prior denileukin diftitox therapy
  3. Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed,
  4. Prior malignancy other than CTCL within past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix)
  5. Major surgery within 2 weeks of study enrollment
  6. Significant or uncontrolled infections requiring specific anti-infective therapy
  7. Females who are pregnant (positive urine test) or breastfeeding
  8. Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.