A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
NCT ID: NCT01871727
Last Updated: 2024-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2013-05-30
2021-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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E7777
E7777 9 mcg/kg
administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days
Interventions
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E7777 9 mcg/kg
administered by intravenous (i.v.) infusion over 60 minutes (+/-10 minutes) on 5 consecutive days during every cycle of 21 days
Eligibility Criteria
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Inclusion Criteria
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 lesions by immunohistochemistry.
4. 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
5. 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.
6. 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.
7. 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.
8. 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.
9. 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
10. 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)
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 1gram.
12. Provide written informed consent prior to any study-specific screening procedures.
13. Females may not be lactating or pregnant at Screening or Baseline
14. All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically
15. Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partner must meet the criteria above
Exclusion Criteria
1. Prior denileukin diftitox therapy
2. 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.
3. 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.
4. Serious intercurrent illness
5. 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)
6. Significant pulmonary symptoms or disease
7. History of uncontrolled seizure disorder or active central nervous system disease
8. Major surgery within 2 weeks of study enrollment
9. Significant or uncontrolled infections requiring systemic anti-infective therapy
10. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or hepatitis C infection
11. Females who are pregnant (positive urine test) or breastfeeding
12. 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.
18 Years
ALL
No
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Citius Pharmaceuticals, Inc.
INDUSTRY
Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Foss FM, Kim YH, Prince HM, Akilov OE, Querfeld C, Seminario-Vidal L, Fisher DC, Kuzel TM, Yannakou CK, Geskin LJ, Feldman T, Sokol L, Allen PB, Dang NH, Cabanillas F, Wong HK, Ooi CE, Xing D, Sauter N, Singh P, Czuczman M, Duvic M. Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. J Clin Oncol. 2025 Apr;43(10):1198-1209. doi: 10.1200/JCO-24-01549. Epub 2024 Dec 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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E7777-G000-302
Identifier Type: -
Identifier Source: org_study_id
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