Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
Sponsor
Hiroshima University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05863234
Collaborator
(none)
6
1
1
23.4
0.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Apr 20, 2023
Anticipated Primary Completion Date
:
Mar 31, 2025
Anticipated Study Completion Date
:
Mar 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment with PPMX-T003
|
Drug: PPMX-T003
The therapeutic agent is administered continuously intravenously
|
Outcome Measures
Primary Outcome Measures
- Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the study [35days]
Secondary Outcome Measures
- Assessment of improvement of liver lesions [by computed tomography (CT) scan] [35 days]
- Assessment of the serum drug concentration of PPMX-T003, calculate each PK parameters [35 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hiroshima University Hospital | Hiroshima | Japan | 734-8551 |
Sponsors and Collaborators
- Hiroshima University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hiroshima University Hospital
ClinicalTrials.gov Identifier:
NCT05863234
Other Study ID Numbers:
- PPMX-T003-CT103
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hiroshima University Hospital
Additional relevant MeSH terms: