Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

Phase 2RecruitingNCT05863234

Hiroshima University Hospital7 enrolled

Overview

This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aggressive NK Cell Leukemia

Interventions

PPMX-T003DRUG

The therapeutic agent is administered continuously intravenously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria. Exclusion Criteria: * Patients eligible to receive chemotherapy as treatment for ANKL

Locations (1)

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

RECRUITING

Outcomes

Primary Outcomes

Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)

In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the first course, incidence of AEs and DLTs by the treatment are measured.

Time frame: 7days after the administration

Secondary Outcomes

Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)

In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the second course or later, incidence of AEs and DLTs by the treatment are measured.

Time frame: From the second course to the final course (Max. 35days after the first administration)

Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan

As a part of efficacy evaluation of the treatment, percentage change in the product of the maximum long and short diameters of the liver measured by CT (assessed by the primary physician)

Time frame: 35 days

Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na)

Time frame: 35 days

Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months

Time frame: 6 months

Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy

Time frame: 35days after the treatment

Central Contacts

Kiyoshi Ando

CONTACT

+81 82-257-5555 andok@keyaki.cc.u-tokai.ac.jp

Data from ClinicalTrials.gov

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