Clinical trial NCT01401530: E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Official title: Phase1/1b Clinical Trial of E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral T-Cell Lymphoma
Keywords: Neoplasms
Neoplasms by Histologic Type
Lymphoma
Non-Hodgkin
T- Cell
Lymphatic Diseases
Lymphoproliferative Disorders
lmmune System Diseases
lmmunoproliferative Disorders
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through observation of dose limiting toxicity (DLT), which is in advance defined, in patients with peripheral or cutaneous T-cell lymphoma.


Eligibility criteria: lnclusion Criteria:

* Male and female patients 20 to less than 80 years of age at the time of informed consent
* Patients histologically or cytologically diagnosed to have peripheral T -cell lymphoma
* Patients with a history of chemotherapy (including PUVA and retinoid) that resulted in relapse, recurrence and treatment resistance (just for the administration of E7777 alone)
* Patients subject to CHOP therapy and without a history of prior treatment with anthracycline or anthraquinone anticancer drugs (just for the administration of E7777 in combination with CHOP therapy)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* No carry-over of beneficial or adverse effects of the prior treatment that may affect the safety evaluation of the investigational drug (excluding Grade 1 neuropathy and alopecia)

Exclusion Criteria:

* Brain metastasis with clinical symptoms which requires treatment
* Serious systemic infection requiring intensive treatment
* Serious complications or histories
* History of hypersensitivity to protein therapeutics
* Known to be positive for HIV antibody, HCV antibody, or HBs antigen
* History of malignancy other than peripheral T-cell lymphoma and less than five years have elapsed since the last remission
* Patients who have undergone allogeneic hematopoietic stem cell transplantation
* Patients with a relapse within 6 months after autologous hematopoietic stem-cell transplantation

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and Recommended Dose (RD)
timeFrame: For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)
Secondary outcomes:
measure: Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox
timeFrame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months
measure: Maximum Serum Concentration (Cmax) of Denileukin Diftitox
timeFrame: Cycle 1 (Day 1)
measure: Time to Cmax (Tmax) of Denileukin Diftitox in Serum
timeFrame: Cycle 1 (Day 1)
measure: Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))
timeFrame: Cycle 1 (Day 1)
measure: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf))
timeFrame: Cycle 1 (Day 1)
measure: Terminal Phase Rate Constant (λz)
timeFrame: Cycle 1 (Day 1)
measure: Terminal Elimination Phase Half-life (t1/2)
timeFrame: Cycle 1 (Day 1)
measure: Volume of Distribution at Terminal Phase (Vz)
timeFrame: Cycle 1 (Day 1)
measure: Volume of Distribution at Steady State (Vss)
timeFrame: Cycle 1 (Day 1)
measure: Total Clearance (CL)
timeFrame: Cycle 1 (Day 1)
measure: Recommended Dose
timeFrame: For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Isehara
country: Japan
state: Kanagawa
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Eisai Co., Ltd.
name: Tadashi Nakanishi
role: STUDY_DIRECTOR
References:
citation: Ohmachi K, Ando K, Ogura M, Uchida T, Tobinai K, Maruyama D, Namiki M, Nakanishi T. E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma: A phase I study. Cancer Sci. 2018 Mar;109(3):794-802. doi: 10.1111/cas.13513. Epub 2018 Feb 26.