Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
ConditionAggressive NK Cell Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHiroshima University Hospital
About this trial
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients eligible to receive chemotherapy as treatment for ANKL
Trial design
Design model
Single group
Treatments tested in this trial
PPMX-T003
DrugThe therapeutic agent is administered continuously intravenously
Treatment groups
7 Participants
are divided into 1 treatment groupGroup A: Treatment with PPMX-T003Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 administrationSecondary outcomes
1
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)2
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 days3
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 days4
Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hiroshima University Hospital
Lead sponsor
Kyoto University Hospital
Collaborator
Hokkaido University Hospital
Collaborator
Okayama University
Collaborator
Tokai University
Collaborator
Kyushu University
Collaborator
Tohoku University
Collaborator
Nagoya University
Collaborator
Komagome Hospital
Collaborator
Source ClinicalTrials.gov