Back to resultsSafety Evaluation Study for Patients With Aggressive NK-cell Leukemia
Primary Purpose
Aggressive NK Cell Leukemia
Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
PPMX-T003
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive NK Cell Leukemia focused on measuring neoplasms
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
Sites / Locations
- Hiroshima University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with PPMX-T003
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the study
Secondary Outcome Measures
Assessment of improvement of liver lesions [by computed tomography (CT) scan]
Assessment of the serum drug concentration of PPMX-T003, calculate each PK parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05863234
Brief Title
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hiroshima University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive NK Cell Leukemia
Keywords
neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with PPMX-T003
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PPMX-T003
Intervention Description
The therapeutic agent is administered continuously intravenously
Primary Outcome Measure Information:
Title
Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the study
Time Frame
35days
Secondary Outcome Measure Information:
Title
Assessment of improvement of liver lesions [by computed tomography (CT) scan]
Time Frame
35 days
Title
Assessment of the serum drug concentration of PPMX-T003, calculate each PK parameters
Time Frame
35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiyoshi Ando
Phone
+81 82-257-5555
Email
andok@keyaki.cc.u-tokai.ac.jp
Facility Information:
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyoshi Ando
Phone
+81 82-257-5555
Email
andok@keyaki.cc.u-tokai.ac.jp
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
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