Trial · NCT01871727
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
NCT01871727, Phase 3, Completed, Eisai Inc.; results first posted 2024-11-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma. Trials, record NCT01871727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01871727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
- NCT number
- NCT01871727
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 112 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Persistent or Recurrent Cutaneous T-Cell Lymphoma
- Interventions
- E7777 9 mcg/kg
- First posted
- 2013-06-07
- Last updated
- 2024-11-13
- Results first posted
- 2024-11-13
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | Cycle 1 (cycle length was 21 days) | DLTs as per NCI CTCAE v4.03 were defined as 1) serious infusion reaction (CTCAE) Grade 4 adverse event of "Infusion related reaction," or recurrent CTCAE Grade 3 despite administration of systemic steroid premedication after initial occurrence. Infusion reactions were defined as symptoms (example, fatigue, nausea, vomiting, arthralgia, myalgia, pyrexia, chills, rigors) occurring within 24 hours of E7777 infusion. 2) Capillary leak syndrome (CLS) CTCAE Grade 4 or Grade 3 (with exceptions). A CLS event was defined as the noted occurrence of at least 2 of the following: hypotension, edema, or serum albumin less than (\<) 3.0 gram per decilitre (g/dL). 3) Clinical visual impairment. 4) Any CTCAE Grade greater than or equal to (\>=) 4 adverse event (AE) that may represent an infusion reaction. 5) Any other Grade 3 or greater toxicity assessed as related to E7777 treatment and which in the opinion of a safety consultancy investigator panel, was a dose-limiting toxicity. |
| Primary | Lead-In Part: Maximum Tolerated Dose (MTD) of E7777 | Cycle 1 (cycle length was 21 days) | The MTD was defined as the safe dose level established in Lead-In Part. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the Lead-In Part. |
| Primary | Main Study Part: Objective Response Rate (ORR) by Independent Review Committee (IRC) Based on Olsen 2011 Criteria | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review committee on 2 assessments at least 3 weeks apart. The tumor response was based on global response score (GRS) Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. |
| Secondary | Lead-In Part: Duration of Response (DOR) Per Investigator Assessment | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months) | DOR per investigator assessment was defined as the time from date when criteria for response (CR or PR) was first met until the date of the first documentation of disease progression (PD) or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir. |
| Secondary | Main Study Part: Duration of Response (DOR) Per Independent Review Committee | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 3 years 6 months) | DOR per independent review committee was defined as the time from the date when criteria for response (CR or PR) was first met until the date of the first documentation of PD or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir. |
| Secondary | Lead-In Part: Time to Response (TTR) Per Investigator Assessment | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months) | Time to response per investigator assessment was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. |
| Secondary | Main Study Part: Time to Response (TTR) Per Independent Review Committee | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months) | Time to response per independent review committee was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. |
| Secondary | Lead-In Part and Main Study Part: ORR Per Investigator Assessment | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | ORR per investigator assessment was defined as the percentage of participants whose BOR was CR or PR. The tumor response was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. |
| Secondary | Main Study Part: ORR Per IRC Based on Prince 2010 Criteria | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | ORR was defined as the percentage of participants whose BOR was CR, clinical complete response (CCR) or PR per IRC. The tumor response was based on Prince 2010 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. CCR was defined as tumor residue not visible on esophagogram, computed tomography (CT), endoscopy, positron emission tomography (PET)-CT. |
| Secondary | Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months) | TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | Cycle 1 (cycle length was 21 days) | Lead-in analysis set included all participants enrolled in lead-in part. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Lead-In Part: Maximum Tolerated Dose (MTD) of E7777 | Cycle 1 (cycle length was 21 days) | Dose-finding analysis set included all participants in the Lead-in part who completed Cycle 1 treatment and were evaluated for DLT, and those who discontinued during Cycle 1 due to DLT. | mcg/kg | NUMBER |
| PRIMARY | Main Study Part: Objective Response Rate (ORR) by Independent Review Committee (IRC) Based on Olsen 2011 Criteria | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose | percentage of participants | NUMBER |
| SECONDARY | Lead-In Part: Duration of Response (DOR) Per Investigator Assessment | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months) | Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead in part. | days | MEDIAN |
| SECONDARY | Main Study Part: Duration of Response (DOR) Per Independent Review Committee | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 3 years 6 months) | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here, 'overall number of participants analyzed' were those who had CR or PR in Lead-in part and in Main study part. | months | MEDIAN |
| SECONDARY | Lead-In Part: Time to Response (TTR) Per Investigator Assessment | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 1 year 2 months) | Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead-in part of the study. | days | MEDIAN |
| SECONDARY | Main Study Part: Time to Response (TTR) Per Independent Review Committee | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months) | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here, 'overall number of participants analyzed' were those who had CR or PR in Lead-in part and in Main study part. | months | MEDIAN |
| SECONDARY | Lead-In Part and Main Study Part: ORR Per Investigator Assessment | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | Lead-in analysis set included all participants enrolled in the lead-in part and Investigator efficacy analysis set included all Stage I to III participants (both Main Study \[n=66\] and Lead-In \[n=5\]) who received study drug at 9 mcg/kg dose. | percentage of participants | NUMBER |
| SECONDARY | Main Study Part: ORR Per IRC Based on Prince 2010 Criteria | From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months) | Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. | percentage of participants | NUMBER |
| SECONDARY | Lead-In Part and Main Study Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to 30 days after the last dose (Up to 3 years and 7 months) | Lead-In Part: SAS included all participants who received study drug. Main Study Part: SAS included all participants (both Main Study and Lead-In) who received study drug at 9 mcg/kg. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | Lead-In Part: E7777 6 mcg/kg | 0 | Participants | ||
| Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | Lead-In Part: E7777 9 mcg/kg | 0 | Participants | ||
| Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | Lead-In Part: E7777 12 mcg/kg | 0 | Participants | ||
| Lead-In Part: Number of Participants With Dose-limiting Toxicities (DLTs) as Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) | Lead-In Part: E7777 15 mcg/kg | 2 | Participants | ||
| Lead-In Part: Maximum Tolerated Dose (MTD) of E7777 | Lead-In Part: E7777 | 12.0 | mcg/kg | ||
| Main Study Part: Objective Response Rate (ORR) by Independent Review Committee (IRC) Based on Olsen 2011 Criteria | Main Study Part: E7777 9 mcg/kg | 36.2 | 95% Confidence Interval 25.0 to 48.7 | percentage of participants | |
| Lead-In Part: Duration of Response (DOR) Per Investigator Assessment | Lead-In Part: E7777 6 mcg/kg | 43.0 | Full Range 43 to 43 | days | |
| Lead-In Part: Duration of Response (DOR) Per Investigator Assessment | Lead-In Part: E7777 9 mcg/kg | 106.0 | Full Range 71 to 134 | days | |
| Lead-In Part: Duration of Response (DOR) Per Investigator Assessment | Lead-In Part: E7777 12 mcg/kg | 113.0 | Full Range 92 to 351 | days | |
| Main Study Part: Duration of Response (DOR) Per Independent Review Committee | Main Study Part: E7777 9 mcg/kg | 6.47 | Full Range 3.0 to 23.5 | months |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-In Part (1 Year 2 Months) | STARTED | Lead-In Part: E7777 6 mcg/kg | 2 | |
| Lead-In Part (1 Year 2 Months) | STARTED | Lead-In Part: E7777 9 mcg/kg | 8 | |
| Lead-In Part (1 Year 2 Months) | STARTED | Lead-In Part: E7777 12 mcg/kg | 9 | |
| Lead-In Part (1 Year 2 Months) | STARTED | Lead-In Part: E7777 15 mcg/kg | 2 | |
| Lead-In Part (1 Year 2 Months) | STARTED | Main Study Part: E7777 9 mcg/kg | 0 | |
| Lead-In Part (1 Year 2 Months) | Primary Efficacy Analysis Set | Lead-In Part: E7777 6 mcg/kg | 0 | |
| Lead-In Part (1 Year 2 Months) | Primary Efficacy Analysis Set | Lead-In Part: E7777 9 mcg/kg | 5 | |
| Lead-In Part (1 Year 2 Months) | Primary Efficacy Analysis Set | Lead-In Part: E7777 12 mcg/kg | 0 | |
| Lead-In Part (1 Year 2 Months) | Primary Efficacy Analysis Set | Lead-In Part: E7777 15 mcg/kg | 0 | |
| Lead-In Part (1 Year 2 Months) | Primary Efficacy Analysis Set | Main Study Part: E7777 9 mcg/kg | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events664
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Lead-In Part: E7777 6 mcg/kg | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Lead-In Part: E7777 12 mcg/kg | 3 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Lead-In Part: E7777 15 mcg/kg | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Lead-In Part and Main Study Part: E7777 9 mcg/kg | 8 | 98 | |
| other | Atrial fibrillation | Cardiac disorders | Lead-In Part: E7777 6 mcg/kg | 0 | 2 | |
| other | Atrial fibrillation | Cardiac disorders | Lead-In Part: E7777 12 mcg/kg | 0 | 9 | |
| other | Atrial fibrillation | Cardiac disorders | Lead-In Part: E7777 15 mcg/kg | 1 | 2 | |
| other | Atrial fibrillation | Cardiac disorders | Lead-In Part and Main Study Part: E7777 9 mcg/kg | 0 | 98 | |
| other | Tachycardia | Cardiac disorders | Lead-In Part: E7777 6 mcg/kg | 0 | 2 | |
| other | Tachycardia | Cardiac disorders | Lead-In Part: E7777 12 mcg/kg | 1 | 9 |
1 to 10 of 664Source ClinicalTrials.gov
See all 664 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lead-In Part: E7777 6 mcg/kg | 0 | 2 |
| Total, all-cause mortality | Lead-In Part: E7777 12 mcg/kg | 3 | 9 |
| Total, all-cause mortality | Lead-In Part: E7777 15 mcg/kg | 0 | 2 |
| Total, all-cause mortality | Lead-In Part and Main Study Part: E7777 9 mcg/kg | 13 | 98 |
| Total, other adverse events | Lead-In Part: E7777 6 mcg/kg | 2 | 2 |
| Total, other adverse events | Lead-In Part: E7777 12 mcg/kg | 9 | 9 |
| Total, other adverse events | Lead-In Part: E7777 15 mcg/kg | 1 | 2 |
| Total, other adverse events | Lead-In Part and Main Study Part: E7777 9 mcg/kg | 95 | 98 |
| Total, serious adverse events | Lead-In Part: E7777 6 mcg/kg | 0 | 2 |
| Total, serious adverse events | Lead-In Part: E7777 12 mcg/kg | 4 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39700456 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01871727
GET https://conductscience.org/api/trials/v1/NCT01871727/registered?page=2