Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01871727




Registration number
NCT01871727
Ethics application status
Date submitted
28/03/2013
Date registered
7/06/2013
Date last updated
12/12/2022

Titles & IDs
Public title
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
Scientific title
A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma
Secondary ID [1] 0 0
E7777-G000-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent or Recurrent Cutaneous T-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - E7777 9 mcg/kg

Experimental: E7777 -


Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting toxicities (DLTs) in the Lead-In Part
Timepoint [1] 0 0
Cycle 1 (21 days)
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD) in the Lead-In Part
Timepoint [2] 0 0
Up to12 months
Primary outcome [3] 0 0
ORR in the Main study
Timepoint [3] 0 0
Day 1 until disease progression/recurrence, or up to 30 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Day 1 until disease progression/recurrence, or up to 12 months (Lead-in Part) and Day 1 until disease progression/recurrence, or up to 30 months (Main Study)
Secondary outcome [2] 0 0
Time to Response (TTR)
Timepoint [2] 0 0
Up to 12 months (Lead-In Part) and up to 30 months (Main study)
Secondary outcome [3] 0 0
ORR
Timepoint [3] 0 0
Day 1 until disease progression/recurrence, up to 12 months (Lead-in Part) and Day 1 until disease progression/recurrence, up to 30 months (by using Prince (2010) criteria in Main Study)
Secondary outcome [4] 0 0
Number of Participants with Any Adverse Event and Any Serious Adverse Event (SAE)
Timepoint [4] 0 0
From first dose of the study drug until 30 days after the last dose, or up to 30 months
Secondary outcome [5] 0 0
Maximum Drug Concentration (Cmax)
Timepoint [5] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length is equal to [=] 21 days)
Secondary outcome [6] 0 0
Area Under the Curve from Time 0 to Time t (AUC[0-t])
Timepoint [6] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length=21 days)
Secondary outcome [7] 0 0
Area Under the Curve from Time 0 to Time Infinity (AUC[0-inf])
Timepoint [7] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length=21 days)
Secondary outcome [8] 0 0
Terminal Elimination Half-life (t1/2)
Timepoint [8] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length=21 days)
Secondary outcome [9] 0 0
Time to Reach Maximum (peak) Concentration After Drug Administration (Tmax)
Timepoint [9] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length=21 days)
Secondary outcome [10] 0 0
Total Body Clearance (CL)
Timepoint [10] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length=21 days)
Secondary outcome [11] 0 0
Volume of Distribution at Steady State (Vdss)
Timepoint [11] 0 0
Cycles 1, 3, 5 Day 1: pre-dose-300 minutes post infusion stop (Lead-in part and for first 12 participants in the Main study) (Cycle length=21 days)
Secondary outcome [12] 0 0
Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies
Timepoint [12] 0 0
Da y 1 of Cycles 1, 2, 3, 5, and 8 (for Anti-E7777 and Anti-IL-2); Anti-IL-2 is to be tested at 6 month, 1 year, and thereafter every year until antibody levels decrease to baseline levels
Secondary outcome [13] 0 0
Number of Participants with Skin Response in the Main Study
Timepoint [13] 0 0
Day 1 until disease progression/recurrence, or up to 30 months
Secondary outcome [14] 0 0
Duration of Skin Response in the Main Study
Timepoint [14] 0 0
Day 1 until disease progression/recurrence, or up to 30 months
Secondary outcome [15] 0 0
Time to Skin Response in the Main Study
Timepoint [15] 0 0
Up to 30 months

Eligibility
Key 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 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

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

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2021
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Epworth Healthcare Freemasons - East Melbourne
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Puerto Rico
State/province [13] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Dr. Reddy's Laboratory
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Citius Pharmaceuticals
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01871727