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Clinical Trial 19390

Cancer Type:
Interventions:E7777

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Lubomir Sokol

Overview

Study Title

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

Summary

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.

Objective

STUDY OBJECTIVES LEAD-IN PART Primary Objectives: To establish the maximum tolerated dose (MTD) of E7777 and to select the dose of E7777 to be used in the Main Study. Secondary Objectives: To assess safety, tumor response, pharmacokinetics (PK), and immunogenicity after treatment with E7777. MAIN STUDY Primary Objective: To demonstrate efficacy of E7777 in subjects with recurrent or persistent CTCL as assessed by objective response rate (ORR; Objective Response is Complete Response [CR] and Partial Response [PR], according to ISCL/EORTC Global Response Score [Olsen 2011]). Secondary Objectives: To determine the efficacy endpoint of Duration of Response (DOR) for E7777. To determine time to response after E7777 treatment. To determine skin response after E7777 treatment. To determine duration of skin Response after E7777 treatment. To determine time to skin response after E7777 treatment. To assess objective response rate (ORR) for E7777 using the alternate response assessment criteria of Prince (2010)5. To evaluate safety and tolerability of E7777. To characterize the pharmacokinetics (PK) of E7777 and immunogenicity after treatment with E7777. Exploratory Objectives: To assess two efficacy endpoints for subjects treated with E7777: progression-free survival (PFS) and time to progression (TTP) (using Global Response Score). To assess pruritus improvement reported by subjects treated with E7777. To assess Quality of Life (QoL) for subjects treated with E7777.

Inclusion Criteria

  • Age greater than or equal to 18 years.
  • Histopathologic diagnosis of Cutaneous T-Cell Lymphoma (CTCL) [mycosis fungoides (MF) or Sezary Syndrome (SS)], confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.
  • 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.
  • CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011). Lead-In Phase: Stage IA - IV, except participants with central nervous system (CNS) involvement. Main Study: Stage IA - IVA2 including lymph node disease N2 and N3.
  • 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.
  • A minimum washout period of 4 weeks after previous CTCL therapy is recommended before the first dose of E7777. Participants must have recovered from any adverse effects from any previous CTCL therapy to CTCAE Grade less than 2 before starting study drug. A shorter washout may be allowed if participant is experiencing progressive disease despite ongoing treatment.
  • 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.
  • 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.
  • Adequate bone marrow reserves.
  • Normal hepatic function.
  • Adequate renal function.
  • Provide written informed consent prior to any study-specific screening procedures.
  • Females may not be lactating or pregnant at Screening or Baseline.
  • All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.
  • Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partner must meet the criteria above.

    • Exclusion Criteria

  • Prior denileukin diftitox therapy.
  • Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed.
  • Active malignancy (except for CTCL, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix) within the past 24 months.
  • Serious intercurrent illness.
  • Significant cardiac disease requiring ongoing treatment, including congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI).
  • Significant pulmonary symptoms or disease.
  • History of uncontrolled seizure disorder or active central nervous system disease.
  • Major surgery within 2 weeks of study enrollment.
  • Significant or uncontrolled infections requiring specific anti-infective therapy.
  • Known human immunodeficiency virus (HIV) infection; known active hepatitis B or hepatitis C infection.
  • Females who are pregnant (positive urine test) or breastfeeding.
  • 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.

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