Phase 2
N=37
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
Peripheral T-cell Lymphoma · Cutaneous T-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02676778 ↗Enrolled (actual)
37
Serious AEs
46.0%
Results posted
Jul 2021
Primary outcome: Primary: Objective Response Rate (ORR) — 41.2; 31.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- E7777 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
41.2; 31.6 | — |
| SECONDARY Progression Free Survival (PFS) |
2.14; 4.24 | — |
| SECONDARY Duration of Response (DOR) |
3.09; 4.83 | — |
| SECONDARY Time to Response (TTR) |
1.28; 2.12 | — |
| SECONDARY CR Rate |
5.9; 0 | — |
| SECONDARY Overall Survival (OS) |
11.79; 31.87 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
17; 19; 1; 9; 8; 0 | — |
| SECONDARY Cmax: Maximum Observed Serum Concentration for E7777 |
132; 142; 140 | — |
| SECONDARY Tmax: Time to Reach the Cmax for E7777 |
63.00; 65.00; 80.00 | — |
| SECONDARY AUC(0-t ): Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Point for E7777 |
17600; 15800; 16500 | — |
| SECONDARY AUC(0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for E7777 |
23000; 21400 | — |
| SECONDARY Mean Residence Time (MRT) for E7777 |
136; 105 | — |
| SECONDARY t1/2: Terminal Elimination Phase Half-life for E7777 |
96.0; 116; 69.2 | — |
| SECONDARY CL: Total Clearance for E7777 |
0.465; 0.421 | — |
| SECONDARY Vz: Volume of Distribution at Terminal Phase for E7777 |
59.0; 42.0 | — |
| SECONDARY Vss: Volume of Distribution at Steady State for E7777 |
57.4; 44.1 | — |
| SECONDARY Rac (Cmax): Accumulation Ratio of Cmax for E7777 |
0.993; 0.979 | — |
| SECONDARY Rac (AUC): Accumulation Ratio of AUC for E7777 |
0.827 | — |
| SECONDARY Number of Participants With Positive Anti-E7777 and Anti-IL-2 Antibodies |
11; 13; 1; 5; 11; 0 | — |
| SECONDARY Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody |
0; 0; 0; 2; 9; 0 | — |
Summary
The purpose of this study is to evaluate the objective response rate (ORR) of E7777 in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
Eligibility Criteria
Inclusion Criteria
- Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
- Participant who have measurable disease.
- Participant who had previous systemic chemotherapy.
- Participant who had disease progression (PD) or did not have response (complete response (CR) or partial response (PR)) in systemic chemotherapy, or relapsed or progressed after systemic chemotherapy.
- Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Participant with adequate renal, liver and bone marrow function.
- Male and female participants ≥20 years of age at the time of informed consent.
- Participants who have provided written consent to participate in the study.
Exclusion Criteria
- Participant with serious complications or histories.
- Participant with history of hypersensitivity to protein therapeutics.
- Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.
- Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.
- Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.
- Woman who is pregnant or lactating.
- Participant with allogeneic stem cell transplantation.
- Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.
Data sourced from ClinicalTrials.gov (NCT02676778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.