A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT01871727 |
Recruitment Status :
Completed
First Posted : June 7, 2013
Last Update Posted : December 12, 2022
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Tracking Information | |||
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First Submitted Date ICMJE | March 28, 2013 | ||
First Posted Date ICMJE | June 7, 2013 | ||
Last Update Posted Date | December 12, 2022 | ||
Actual Study Start Date ICMJE | May 30, 2013 | ||
Actual Primary Completion Date | December 6, 2021 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Objective Response Rate (ORR) [ Time Frame: 36 months ] Objective Response Rate is defined as the proportion of subjects with best response of complete response (CR) or partial response (PR) using the Global Response Score of the consensus International Society for Cutaneous Lymphomas/ European Organization of Research and Treatment of Cancer (ISCL/EORTC) criteria.
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Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma | ||
Official Title ICMJE | A Clinical Study to Demonstrate Safety and Efficacy of E7777 in Persistent or Recurrent Cutaneous T-Cell Lymphoma | ||
Brief Summary | 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. | ||
Detailed Description | This is a multicenter, open-label study of E7777 in participants with recurrent or persistent CTCL. The study consists of an initial Lead-in part (to select recommended dose of E7777 for Main part), followed by the Main part (to test efficacy). Participants will move through three phases while on study: Pretreatment Phase, Treatment Phase, and Extension Phase and a Follow-up Period. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Persistent or Recurrent Cutaneous T-Cell Lymphoma | ||
Intervention ICMJE | Drug: 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
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Study Arms ICMJE | Experimental: E7777
Intervention: Drug: E7777 9 mcg/kg
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
112 | ||
Original Estimated Enrollment ICMJE |
90 | ||
Actual Study Completion Date ICMJE | December 14, 2021 | ||
Actual Primary Completion Date | December 6, 2021 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria: Participants must meet all of the following criteria to be included in the study:
Exclusion Criteria Participants who meet any of the following criteria will be excluded from the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Puerto Rico, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01871727 | ||
Other Study ID Numbers ICMJE | E7777-G000-302 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Eisai Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Eisai Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||
PRS Account | Eisai Inc. | ||
Verification Date | November 2022 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |