Aggressive NK-cell Leukemia
Conditions
Interventions
Repeated and continuous intravenous administration of the investigational drug (PPMX-T003).
Multiple starting doses.
Sponsors
ando kiyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are at least 18 years old and less than 75 years old at the time of obtaining consent 2) Patients confirmed to have been diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organisation (WHO) 4th edition (2017) criteria. 3) Patients with abnormal liver function or hepatomegaly due to the primary disease 4) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status(PS) of 3 or less 5) For women of childbearing potential, women of childbearing potential and men, patients who agree to use adequate contraception from the time consent is obtained until 24 weeks after the last dose. 6) Patients for whom written consent to participate in this clinical trial has been obtained from the individual or a surrogate.
Exclusion criteria
Exclusion criteria: 1) Patients eligible to receive chemotherapy as treatment for ANKL 2) Patients whose tests performed at screening show abnormalities not attributable to the underlying disease (ANKL) and who have been judged by the investigator or others to be problematic for study participation (e.g. physical examination, standard 12-lead ECG, chest radiography, haematology, blood chemistry, urine analysis, immunological tests, etc.) 3) Patients treated with other investigational drugs or unapproved therapies within 16 weeks prior to enrolment 4) Patients who, at the time of screening, had not received hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb), hepatitis B virus surface antibody (HBcAb), hepatitis B virus core antibody (HBcAb), hepatitis B virus core antibody (HBcAb) or hepatitis B virus surface antibody (HBcAb), Hepatitis B virus surface Antibody (HBsAb), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody/antigen, or syphilis serological response positive. (except that HBsAb positive with a vaccination history, HBsAb positive but negative for HBV-DNA* and HCV antibody positive but negative for HCV-RNA*.) 5) Pregnant and lactating female patients 6) Other patients deemed inappropriate by the investigator or others to participate in this study. *Hepatitis virus testing should be performed once a month during the period of administration to ensure that there are no safety issues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability and safety of PPMX-T003 repeated continuous intravenous administration (first course) Evaluation Criteria: Incidence of AEs and DLTs | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety of PPMX-T003 repeated continuous intravenous administration (including DLT evaluation after the second course) Efficacy of PPMX-T003 repeated continuous intravenous infusion(Percentage change in the product of the maximum long and short diameters of the liver measured by CT (assessed by the primary physician),Improvement in liver function as assessed by the Model for End-Stage Liver Disease (MELD and MELD-Na) ,Survival duration at 6 months,Percentage of subjects who were able to transition to chemotherapy) Serum drug concentrations during repeated and continuous intravenous PPMX-T003 administration Anti-drug antibody production | — |
Contacts
Public Contactkiyoshi ando
Hiroshima University Hospital
Outcome results
None listed