Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma

Eisai

Status and phase: Completed; Phase 2

Conditions: Cutaneous T-cell Lymphoma; Peripheral T-cell Lymphoma

Treatments: Drug: E7777

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676778

E7777-J081-205

Details and patient eligibility

About

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).

Full description

This is a multicenter, single-arm, open label, Phase 2 to evaluate efficacy, safety, pharmacokinetics and immunogenicity of E7777 in participants with relapsed or refractory PTCL and CTCL.

Enrollment: 45 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants who have histological diagnosis as peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
2. Participant who have measurable disease.
3. Participant who had previous systemic chemotherapy.
4. 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.
5. Participant with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
6. Participant with adequate renal, liver and bone marrow function.
7. Male and female participants ≥20 years of age at the time of informed consent.
8. Participants who have provided written consent to participate in the study.

Exclusion criteria

1. Participant with serious complications or histories.
2. Participant with history of hypersensitivity to protein therapeutics.
3. Participant who is positive for Human immunodeficiency virus (HIV) antibody, Hepatitis C virus (HCV) antibody, or Hepatitis B Surface (HBs) antigen.
4. Participant with malignancy of activity other than PTCL or CTCL within 36 months before informed consent.
5. Women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception.
6. Woman who is pregnant or lactating.
7. Participant with allogeneic stem cell transplantation.
8. Participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

E7777

Experimental group

Description:

Participants with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) will receive 9 μg/kg/day of E7777, administered by intravenous drip infusion in 60 minutes (± 10 min) for Days 1 through 5 of each cycle in maximum of 8 cycles. Every cycle consists of 3 weeks.

Treatment:

Drug: E7777