RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
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 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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- Patients eligible to receive chemotherapy as treatment for ANKL
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
PPMX-T003
The therapeutic agent is administered continuously intravenously
Locations (1)
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan