Trial · NCT02676778
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
NCT02676778, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2021-07-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma. Trials, record NCT02676778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02676778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
- NCT number
- NCT02676778
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma
- Interventions
- E7777
- First posted
- 2016-02-08
- Last updated
- 2021-07-15
- Results first posted
- 2021-07-15
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month | 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 of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. |
| Secondary | Progression Free Survival (PFS) | From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month | PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. |
| Secondary | Duration of Response (DOR) | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month | DOR: Time between date of first documentation of CR or PR and PD or death due to any cause based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on revised response criteria for malignant lymphoma (Cheson,2007),skin lesion and peripheral blood disease by clinical end points and response criteria in mycosis fungoides and Sezary syndrome(Olsen,2011). DOR was assessed in responders who had CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. PD: Any new lesion or unequivocally increase of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method. Participants with new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored. |
| Secondary | Time to Response (TTR) | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR or death due to any cause (whichever occurred first) up to approximately 3 years 1 month | TTR was defined as time between the date of administration of the first dose of the study drug and the date of first documentation PR or CR based on independent review of Efficacy and Safety Evaluation Committee. PR or CR were assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). TTR was only conducted among responders who had experienced CR or PR. CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. |
| Secondary | CR Rate | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month | CR rate was defined as the percentage of participants whose BOR was CR based on independent review of Efficacy and Safety Evaluation Committee. CR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease. |
| Secondary | Overall Survival (OS) | From date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month | OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at cut-off were censored. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month) | |
| Secondary | Cmax: Maximum Observed Serum Concentration for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) | |
| Secondary | Tmax: Time to Reach the Cmax for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) | |
| Secondary | AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month | The full analysis set (FAS) was defined as a group of participants who received at least 1 dose of the study drug. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month | The FAS was defined as a group of participants who received at least 1 dose of the study drug. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month | The FAS was defined as a group of participants who received at least 1 dose of the study drug. Here overall number of participants analyzed signifies responded participants. | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR or death due to any cause (whichever occurred first) up to approximately 3 years 1 month | The FAS was defined as a group of participants who received at least 1 dose of the study drug. Here overall number of participants analyzed signifies responded participants. | months | MEDIAN |
| SECONDARY | CR Rate | From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month | The FAS was defined as a group of participants who received at least 1 dose of the study drug. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month | The FAS was defined as a group of participants who received at least 1 dose of the study drug. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month) | The safety analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 evaluable postbaseline safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cmax: Maximum Observed Serum Concentration for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) | The pharmacokinetic (PK) analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Tmax: Time to Reach the Cmax for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | minutes | MEDIAN |
| SECONDARY | AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 | Cycle 1 Day 1: 0-240 minutes post-infusion; Cycle 3 and 5 Day 1: 0-120 minutes post-infusion (each Cycle length = 3 weeks) | The PK analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 serum concentration data, and included participants who had been taken frequent blood sampling for non-compartment analysis. PK-evaluable population where data at specified time points was available. | nanogram*minute permilliliter(ng*min/mL) | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | PTCL: E7777 9 mcg/kg/Day | 41.2 | 95% Confidence Interval 18.4 to 67.1 | percentage of participants | |
| Objective Response Rate (ORR) | CTCL: E7777 9 mcg/kg/Day | 31.6 | 95% Confidence Interval 12.6 to 56.6 | percentage of participants | |
| Progression Free Survival (PFS) | PTCL: E7777 9 mcg/kg/Day | 2.14 | 95% Confidence Interval 1.05 to 4.47 | months | |
| Progression Free Survival (PFS) | CTCL: E7777 9 mcg/kg/Day | 4.24 | 95% Confidence Interval 2.56 to NA | months | |
| Duration of Response (DOR) | PTCL: E7777 9 mcg/kg/Day | 3.09 | 95% Confidence Interval 0.92 to 4.76 | months | |
| Duration of Response (DOR) | CTCL: E7777 9 mcg/kg/Day | 4.83 | 95% Confidence Interval 2.66 to NA | months | |
| Time to Response (TTR) | PTCL: E7777 9 mcg/kg/Day | 1.28 | Full Range 1.0 to 2.1 | months | |
| Time to Response (TTR) | CTCL: E7777 9 mcg/kg/Day | 2.12 | Full Range 1.0 to 4.6 | months | |
| CR Rate | PTCL: E7777 9 mcg/kg/Day | 5.9 | 95% Confidence Interval 0.1 to 28.7 | percentage of participants | |
| CR Rate | CTCL: E7777 9 mcg/kg/Day | 0 | 95% Confidence Interval 0.0 to 17.6 | percentage of participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PTCL: E7777 9 mcg/kg/Day | 17 | |
| Overall Study | STARTED | CTCL: E7777 9 mcg/kg/Day | 19 | |
| Overall Study | STARTED | Other: E7777 9 mcg/kg/Day | 1 | |
| Overall Study | COMPLETED | PTCL: E7777 9 mcg/kg/Day | 0 | |
| Overall Study | COMPLETED | CTCL: E7777 9 mcg/kg/Day | 7 | |
| Overall Study | COMPLETED | Other: E7777 9 mcg/kg/Day | 0 | |
| Overall Study | NOT COMPLETED | PTCL: E7777 9 mcg/kg/Day | 17 | |
| Overall Study | NOT COMPLETED | CTCL: E7777 9 mcg/kg/Day | 12 | |
| Overall Study | NOT COMPLETED | Other: E7777 9 mcg/kg/Day | 1 |
Source ClinicalTrials.gov
Adverse events507
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 | Lymphopenia | Blood and lymphatic system disorders | PTCL: E7777 9 mcg/kg/Day | 14 | 17 | |
| other | Lymphopenia | Blood and lymphatic system disorders | CTCL: E7777 9 mcg/kg/Day | 11 | 19 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Other: E7777 9 mcg/kg/Day | 1 | 1 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PTCL: E7777 9 mcg/kg/Day | 9 | 17 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | CTCL: E7777 9 mcg/kg/Day | 3 | 19 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Other: E7777 9 mcg/kg/Day | 1 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | PTCL: E7777 9 mcg/kg/Day | 3 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | CTCL: E7777 9 mcg/kg/Day | 2 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Other: E7777 9 mcg/kg/Day | 0 | 1 | |
| other | Leukocytosis | Blood and lymphatic system disorders | PTCL: E7777 9 mcg/kg/Day | 0 | 17 |
1 to 10 of 507Source ClinicalTrials.gov
See all 507 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PTCL: E7777 9 mcg/kg/Day | 0 | 17 |
| Total, all-cause mortality | CTCL: E7777 9 mcg/kg/Day | 1 | 19 |
| Total, all-cause mortality | Other: E7777 9 mcg/kg/Day | 0 | 1 |
| Total, other adverse events | PTCL: E7777 9 mcg/kg/Day | 17 | 17 |
| Total, other adverse events | CTCL: E7777 9 mcg/kg/Day | 19 | 19 |
| Total, other adverse events | Other: E7777 9 mcg/kg/Day | 1 | 1 |
| Total, serious adverse events | PTCL: E7777 9 mcg/kg/Day | 9 | 17 |
| Total, serious adverse events | CTCL: E7777 9 mcg/kg/Day | 8 | 19 |
| Total, serious adverse events | Other: E7777 9 mcg/kg/Day | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02676778
GET https://conductscience.org/api/trials/v1/NCT02676778/results?page=2