Aggressive NK Cell Leukemia
Conditions
Keywords
neoplasms
Brief summary
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
Interventions
DRUGPPMX-T003
The therapeutic agent is administered continuously intravenously
Sponsors
Kyoto University Hospital
Hokkaido University Hospital
Okayama University
Tokai University
Kyushu University
Tohoku University
Nagoya University
Komagome Hospital
Hiroshima University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course) | 7days after the administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan | 35 days | 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) |
| 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) | 35 days | — |
| Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months | 6 months | — |
| Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later) | From the second course to the final course (Max. 35days after the first administration) | 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. |
| Serum drug concentration during repeated continuous intravenous PPMX-T003 administration | 35 days | — |
| Anti-drug antibody production (Immunogenicity) | 35 days | — |
| Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy | 35days after the treatment | — |
Countries
Japan
Contacts
Primary ContactKiyoshi Ando
Outcome results
None listed