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Trial Title:
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
NCT ID:
NCT05863234
Condition:
Aggressive NK Cell Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Large Granular Lymphocytic
Aggression
Conditions: Keywords:
neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PPMX-T003
Description:
The therapeutic agent is administered continuously intravenously
Arm group label:
Treatment with PPMX-T003
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hiroshima University Hospital
Address:
City:
Hiroshima
Zip:
734-8551
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Kiyoshi Ando
Phone:
+81 82-257-5555
Email:
andok@keyaki.cc.u-tokai.ac.jp
Start date:
April 20, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Hiroshima University Hospital
Agency class:
Other
Source:
Hiroshima University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863234
