RecruitingRecruiting
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
NCT05863234 · Hiroshima University Hospital
In plain English
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Official title
Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)
About this study
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
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
Study design
Enrollment target: 7 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-09-21
Estimated completion: 2026-03-31
Last updated: 2025-04-30
Interventions
Drug: PPMX-T003
Primary outcomes
- • Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course) (7days after the administration)
Sponsor
Hiroshima University Hospital · other
With: Kyoto University Hospital, Hokkaido University Hospital, Okayama University, Tokai University, Kyushu University, Tohoku University, Nagoya University, Komagome Hospital
Contacts & investigators
ContactKiyoshi Ando · contact · andok@keyaki.cc.u-tokai.ac.jp · +81 82-257-5555
All locations (1)
Hiroshima University HospitalRecruiting
Hiroshima, Hiroshima, Japan