A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma

Completed · Phase 3

Conditions studied: Persistent or Recurrent Cutaneous T-Cell Lymphoma

In brief

The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR). A lead-in dose-finding part was used to determine dose level 9 microgram per kilogram (mcg/kg) E7777 that is being used to test efficacy and safety.

Key facts

Study ID

NCT01871727

Run by

Eisai Inc.

People needed

112

Starts

2013-05-30

Expected to finish

2021-12-14

Last updated by the study team

2024-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria to be included in the study:
• Age greater than or equal to 18 years.
• Histopathologic diagnosis of 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 lesions by immunohistochemistry.
• CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).
• Lead-In Part: Stage IA - IV, except participants with CNS involvement.
• Main Study: Stage I - III
• History of prior therapies for CTCL: 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 Common Terminology Criteria for Adverse Events (CTCAE) Grade <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 Part and performance status of 0 or 1 in the Main Study.
• Life expectancy greater than or equal to 3 months in the Lead-In Part and greater than or equal to 12 months in the Main Study.
• Adequate bone marrow reserves as evidenced by:
• platelets greater than or equal to 100,000/mm\^3 (100 x 10\^9/L)
• clinically stable hemoglobin greater than or equal to 9 gram per deciliter (g/dL) (90 g/L) and hematocrit greater than or equal to 27% without transfusion support
• Normal hepatic function as evidenced by:
• bilirubin <= 1.5* upper limit if normal (ULN) and alkaline phosphatase <=3.0*ULN
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0*ULN
• albumin >= 3.0 g/dL (30 g/L)
• 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 1gram.
• 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

You may not qualify if…

• Participants who meet any of the following criteria will be excluded from the study:
• Prior denileukin diftitox therapy
• Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed.Topical steroids or systemic low dose steroids of less than or equal to 10 milligram per day (mg/day) prednisone are allowed in participants 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 what the participant had been receiving for a prolonged period of time.
• 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 systemic 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.

Where it is running

• University of Alabama at Birmingham, Dermatology at Whitaker Clinic — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• City of Hope Medical Center National Medical Center — Duarte, California, United States
• UC Irvine Health-Chao Family Comprehensive Cancer Center — Orange, California, United States
• Stanford University Cancer Center — Stanford, California, United States
• Yale University Cancer Center — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• University of PittsburghMedical Center Presbyterian Shadyside — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The University of TX MD Anderson Cancer Center — Houston, Texas, United States
• Westmead Hospital — Westmead, New South Wales, Australia
• Epworth Healthcare Freemasons — East Melbourne, Victoria, Australia
• Peter MacCallum Cancer Institute — East Melbourne, Victoria, Australia
• Auxilio Mutuo Cancer Center — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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